Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-02 @ 5:21 AM
Study NCT ID:
NCT01012167
Status:
COMPLETED
Last Update Posted:
2022-01-12
First Post:
2009-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D005702', 'term': 'Galantamine'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wcarpent@mprc.umaryland.edu', 'phone': '410-402-7101', 'title': 'William Carpenter, Jr.', 'organization': 'Maryland Psychiatric Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': '1: Oxytocin', 'description': 'Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks', 'otherNumAtRisk': 17, 'otherNumAffected': 4, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '2: Galantamine', 'description': 'Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '3: Placebo', 'description': 'Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.', 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Enuresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}], 'seriousEvents': [{'term': 'hospitalization due to unrelated pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Scale for the Assessment of Negative Symptoms (SANS) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.23', 'spread': '6.91', 'groupId': 'OG000'}, {'value': '36.63', 'spread': '10.09', 'groupId': 'OG001'}, {'value': '36.63', 'spread': '10.61', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.07', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '35.22', 'spread': '10.97', 'groupId': 'OG001'}, {'value': '35.05', 'spread': '10.52', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.27', 'spread': '7.53', 'groupId': 'OG000'}, {'value': '34.06', 'spread': '10.26', 'groupId': 'OG001'}, {'value': '34.22', 'spread': '9.61', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '31.40', 'spread': '6.85', 'groupId': 'OG000'}, {'value': '33.22', 'spread': '10.64', 'groupId': 'OG001'}, {'value': '33.47', 'spread': '8.47', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.17', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '-1.41', 'spread': '3.32', 'groupId': 'OG001'}, {'value': '-1.58', 'spread': '4.84', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.97', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '-1.69', 'spread': '3.46', 'groupId': 'OG001'}, {'value': '-1.47', 'spread': '5.64', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.83', 'spread': '3.74', 'groupId': 'OG000'}, {'value': '-2.53', 'spread': '4.34', 'groupId': 'OG001'}, {'value': '-1.00', 'spread': '4.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'PRIMARY', 'title': 'Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '-0.22', 'spread': '0.47', 'groupId': 'OG001'}, {'value': '0.21', 'spread': '0.83', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '1', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.68', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': '\\* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data.'}, {'type': 'SECONDARY', 'title': 'Scale for the Assessment of Negative Symptoms (SANS) - Avolition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.94', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '2.91', 'spread': '0.88', 'groupId': 'OG001'}, {'value': '2.44', 'spread': '0.97', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.78', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.74', 'groupId': 'OG001'}, {'value': '2.43', 'spread': '0.93', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.85', 'spread': '1.04', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '.084', 'groupId': 'OG001'}, {'value': '2.44', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '0.89', 'groupId': 'OG000'}, {'value': '2.74', 'spread': '0.90', 'groupId': 'OG001'}, {'value': '2.41', 'spread': '0.87', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.43', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.57', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.31', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.43', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.69', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.46', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '0.80', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.42', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '0.86', 'groupId': 'OG001'}, {'value': '2.58', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.27', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '2.46', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '2.60', 'spread': '0.64', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.33', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '0.98', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '0.60', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.37', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.51', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '-0.11', 'spread': '.013', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.50', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.12', 'spread': '0.47', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Scale for the Assessment of Negative Symptoms (SANS) - Alogia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.61', 'groupId': 'OG000'}, {'value': '0.95', 'spread': '0.65', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.69', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '0.80', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '0.80', 'spread': '0.61', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.44', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '0.57', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.35', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.37', 'groupId': 'OG001'}, {'value': '-0.17', 'spread': '0.31', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.46', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.86', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '2.21', 'spread': '0.97', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.90', 'groupId': 'OG000'}, {'value': '1.89', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '2.05', 'spread': '1.12', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '0.91', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '0.99', 'groupId': 'OG001'}, {'value': '1.94', 'spread': '0.98', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '1.05', 'groupId': 'OG001'}, {'value': '1.85', 'spread': '0.94', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.07', 'spread': '0.36', 'groupId': 'OG001'}, {'value': '-0.16', 'spread': '0.47', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.60', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '-0.17', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '-0.19', 'spread': '0.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Brief Psychiatric Rating Scale (BPRS) - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.16', 'spread': '5.66', 'groupId': 'OG000'}, {'value': '30.35', 'spread': '6.66', 'groupId': 'OG001'}, {'value': '32.65', 'spread': '7.09', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.00', 'spread': '7.46', 'groupId': 'OG000'}, {'value': '28.95', 'spread': '7.83', 'groupId': 'OG001'}, {'value': '31.75', 'spread': '7.26', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.07', 'spread': '6.15', 'groupId': 'OG000'}, {'value': '27.83', 'spread': '6.88', 'groupId': 'OG001'}, {'value': '31.72', 'spread': '7.25', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '34.33', 'spread': '5.09', 'groupId': 'OG000'}, {'value': '27.67', 'spread': '6.42', 'groupId': 'OG001'}, {'value': '32.18', 'spread': '6.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data available for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Brief Psychiatric Rating Scale (BPRS) - Psychosis Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.34', 'spread': '3.20', 'groupId': 'OG000'}, {'value': '7.30', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '8.18', 'spread': '3.80', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.40', 'spread': '3.79', 'groupId': 'OG000'}, {'value': '7.21', 'spread': '3.61', 'groupId': 'OG001'}, {'value': '7.90', 'spread': '3.86', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.87', 'spread': '3.60', 'groupId': 'OG000'}, {'value': '7.00', 'spread': '3.48', 'groupId': 'OG001'}, {'value': '8.06', 'spread': '4.09', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.67', 'spread': '2.87', 'groupId': 'OG000'}, {'value': '6.78', 'spread': '3.21', 'groupId': 'OG001'}, {'value': '7.59', 'spread': '4.35', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data available for the 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Calgary Depression Scale (CDS) - Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.37', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '1.07', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '1.54', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.20', 'spread': '2.54', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '1.65', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.29', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.13', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '0.67', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '0.94', 'spread': '1.97', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.67', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '1.45', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Arizona Sexual Experience Questionnaire (ASEX) Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '7.6', 'groupId': 'OG001'}, {'value': '29.0', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '19.2', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '30.0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '3.5', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants who completed at least two weeks follow-up.'}, {'type': 'SECONDARY', 'title': 'Arizona Sexual Experience Questionnaire (ASEX) Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '18.1', 'spread': '6.7', 'groupId': 'OG001'}, {'value': '20.8', 'spread': '6.3', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '7.5', 'groupId': 'OG001'}, {'value': '21.7', 'spread': '7.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '6.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Male participants who completed at least two weeks follow-up.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.8', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '76.6', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '78.3', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '9.0', 'groupId': 'OG000'}, {'value': '76.2', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '10.8', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.7', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '77.5', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '79.7', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '79.1', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '78.9', 'spread': '8.1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '73.9', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '75.1', 'spread': '7.3', 'groupId': 'OG001'}, {'value': '73.7', 'spread': '9.7', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '79.2', 'spread': '8.4', 'groupId': 'OG001'}, {'value': '77.2', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.4', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '80.7', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '76.0', 'spread': '9.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean diastolic blood pressure by treatment and follow-up week', 'unitOfMeasure': 'mm-Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '128.4', 'spread': '16.7', 'groupId': 'OG000'}, {'value': '123.4', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '132.3', 'spread': '19.6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '126.1', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '123.9', 'spread': '15.0', 'groupId': 'OG001'}, {'value': '127.4', 'spread': '22.1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '121.9', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '123.7', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '136.2', 'spread': '25.1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '129.5', 'spread': '21.1', 'groupId': 'OG000'}, {'value': '127.3', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '137.7', 'spread': '17.0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124.8', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '123.8', 'spread': '19.0', 'groupId': 'OG001'}, {'value': '129.9', 'spread': '16.5', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '128.4', 'spread': '20.5', 'groupId': 'OG000'}, {'value': '126.9', 'spread': '20.1', 'groupId': 'OG001'}, {'value': '132.8', 'spread': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124.0', 'spread': '17.5', 'groupId': 'OG000'}, {'value': '129.6', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '134.5', 'spread': '19.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean systolic blood pressure by treatment and follow-up week', 'unitOfMeasure': 'mm-Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '96.5', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '96.2', 'spread': '16.2', 'groupId': 'OG001'}, {'value': '96.4', 'spread': '20.0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.8', 'spread': '19.1', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '16.0', 'groupId': 'OG001'}, {'value': '97.9', 'spread': '18.9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '97.5', 'spread': '16.1', 'groupId': 'OG001'}, {'value': '98.3', 'spread': '18.8', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.0', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '94.5', 'spread': '13.8', 'groupId': 'OG001'}, {'value': '98.4', 'spread': '19.5', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.0', 'spread': '17.9', 'groupId': 'OG000'}, {'value': '95.5', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '100.3', 'spread': '17.7', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.1', 'spread': '18.6', 'groupId': 'OG000'}, {'value': '94.0', 'spread': '14.6', 'groupId': 'OG001'}, {'value': '100.8', 'spread': '17.7', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.6', 'spread': '18.0', 'groupId': 'OG000'}, {'value': '95.1', 'spread': '14.7', 'groupId': 'OG001'}, {'value': '97.9', 'spread': '16.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean weight (kg) by treatment and follow-up week', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Vital Signs - Pulse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81.2', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '86.0', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '85.2', 'spread': '13.4', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.2', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '91.6', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '89.3', 'spread': '16.7', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '82.7', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '91.3', 'spread': '14.2', 'groupId': 'OG001'}, {'value': '87.3', 'spread': '15.3', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.5', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '89.2', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '89.2', 'spread': '13.8', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '79.6', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '88.6', 'spread': '12.9', 'groupId': 'OG001'}, {'value': '83.7', 'spread': '14.2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.4', 'spread': '13.2', 'groupId': 'OG000'}, {'value': '98.6', 'spread': '28.1', 'groupId': 'OG001'}, {'value': '90.5', 'spread': '16.0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '15.0', 'groupId': 'OG000'}, {'value': '85.2', 'spread': '16.6', 'groupId': 'OG001'}, {'value': '84.7', 'spread': '12.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean sitting pulse (bpm) by treatment and follow-up week', 'unitOfMeasure': 'bpm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Simpson-Angus Scale (SAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'No worsening (0)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '63.16', 'groupId': 'OG001'}, {'value': '78.95', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 1', 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000'}, {'value': '10.53', 'groupId': 'OG001'}, {'value': '10.53', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 2', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '15.79', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 3', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '5.26', 'groupId': 'OG001'}, {'value': '5.26', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.26', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 10', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.26', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, week 3, and week 6', 'description': 'SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis.'}, {'type': 'SECONDARY', 'title': 'Abnormal Involuntary Movement Scale (AIMS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'No worsening (0)', 'categories': [{'measurements': [{'value': '86.67', 'groupId': 'OG000'}, {'value': '77.78', 'groupId': 'OG001'}, {'value': '76.47', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 1', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '16.67', 'groupId': 'OG001'}, {'value': '17.65', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 2', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.88', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5.56', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '50 participants who completed the trial.'}, {'type': 'SECONDARY', 'title': 'Electrocardiogram (EKG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '416.5', 'spread': '23.1', 'groupId': 'OG000'}, {'value': '419.0', 'spread': '26.6', 'groupId': 'OG001'}, {'value': '422.6', 'spread': '25.5', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '415.7', 'spread': '28.3', 'groupId': 'OG000'}, {'value': '408.1', 'spread': '27.2', 'groupId': 'OG001'}, {'value': '423.8', 'spread': '26.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '-10.2', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '0.9', 'spread': '20.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during Evaluation and once at Treatment Week 6', 'description': 'Mean corrected QT interval (QTc) by study week and treatment.', 'unitOfMeasure': 'QTc', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '50 participants who completed the trial.'}, {'type': 'SECONDARY', 'title': 'Barnes Akathisia Scale (BAS) - Global Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'No worsening (0)', 'categories': [{'measurements': [{'value': '93.33', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}, {'value': '94.12', 'groupId': 'OG002'}]}]}, {'title': 'Worsening of 1', 'categories': [{'measurements': [{'value': '6.67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5.88', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': '50 participants who completed the trial.'}, {'type': 'SECONDARY', 'title': 'Blood Oxytocin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.'}], 'classes': [{'title': 'Treatment Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.22', 'spread': '15.52', 'groupId': 'OG000'}, {'value': '13.76', 'spread': '6.96', 'groupId': 'OG001'}, {'value': '14.69', 'spread': '7.99', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '17.22', 'spread': '17.02', 'groupId': 'OG000'}, {'value': '10.11', 'spread': '3.42', 'groupId': 'OG001'}, {'value': '13.21', 'spread': '9.32', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.88', 'spread': '14.09', 'groupId': 'OG000'}, {'value': '-2.99', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '-1.73', 'spread': '3.95', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Blood Oxytocin Levels by Treatment and Visit', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - ALT/SGPT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '22.87', 'spread': '8.68', 'groupId': 'OG000'}, {'value': '31.26', 'spread': '22.93', 'groupId': 'OG001'}, {'value': '27.40', 'spread': '19.78', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.67', 'spread': '13.03', 'groupId': 'OG000'}, {'value': '28.90', 'spread': '22.81', 'groupId': 'OG001'}, {'value': '27.74', 'spread': '16.62', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.15', 'spread': '10.20', 'groupId': 'OG000'}, {'value': '-2.65', 'spread': '6.14', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '8.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - AST/SGOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.87', 'spread': '5.46', 'groupId': 'OG000'}, {'value': '22.68', 'spread': '9.68', 'groupId': 'OG001'}, {'value': '22.50', 'spread': '9.29', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.27', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '21.45', 'spread': '10.16', 'groupId': 'OG001'}, {'value': '23.58', 'spread': '9.26', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.46', 'spread': '4.20', 'groupId': 'OG000'}, {'value': '-1.53', 'spread': '8.13', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '5.43', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Alkaline Phosphatase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.47', 'spread': '21.56', 'groupId': 'OG000'}, {'value': '83.42', 'spread': '16.29', 'groupId': 'OG001'}, {'value': '86.40', 'spread': '23.37', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.73', 'spread': '31.09', 'groupId': 'OG000'}, {'value': '82.50', 'spread': '20.50', 'groupId': 'OG001'}, {'value': '88.95', 'spread': '29.67', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.77', 'spread': '15.81', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '10.29', 'groupId': 'OG001'}, {'value': '1.19', 'spread': '10.97', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Alkaline phosphatase blood level by treatment group and visit.', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation at Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.53', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '9.36', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '9.58', 'spread': '0.41', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.57', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '9.23', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '9.54', 'spread': '0.44', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.12', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-0.16', 'spread': '0.21', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Calcium blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.53', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '139.53', 'spread': '2.89', 'groupId': 'OG001'}, {'value': '137.30', 'spread': '4.28', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '138.53', 'spread': '3.02', 'groupId': 'OG000'}, {'value': '139.15', 'spread': '2.16', 'groupId': 'OG001'}, {'value': '137.47', 'spread': '3.96', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.63', 'groupId': 'OG000'}, {'value': '-0.53', 'spread': '3.22', 'groupId': 'OG001'}, {'value': '0.31', 'spread': '2.82', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Sodium blood levels by treatment group and visit.', 'unitOfMeasure': 'mE/qL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Potassium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.20', 'spread': '0.47', 'groupId': 'OG000'}, {'value': '4.14', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '4.17', 'spread': '0.28', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.07', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '4.16', 'spread': '0.39', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.12', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '0.22', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Potassium blood levels by treatment group and visit.', 'unitOfMeasure': 'mE/qL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data at Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Chloride', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.60', 'spread': '2.95', 'groupId': 'OG000'}, {'value': '102.79', 'spread': '3.41', 'groupId': 'OG001'}, {'value': '100.15', 'spread': '4.21', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '101.53', 'spread': '3.54', 'groupId': 'OG000'}, {'value': '102.90', 'spread': '2.63', 'groupId': 'OG001'}, {'value': '100.47', 'spread': '3.78', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '2.70', 'groupId': 'OG001'}, {'value': '0.56', 'spread': '2.80', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Chloride blood levels by treatment group and visit.', 'unitOfMeasure': 'mE/qL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - CO2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.47', 'spread': '2.13', 'groupId': 'OG000'}, {'value': '22.42', 'spread': '3.01', 'groupId': 'OG001'}, {'value': '23.40', 'spread': '2.52', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.27', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '22.50', 'spread': '2.33', 'groupId': 'OG001'}, {'value': '22.83', 'spread': '2.15', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.31', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '2.77', 'groupId': 'OG001'}, {'value': '-0.20', 'spread': '1.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Carbon Dioxide (CO2) blood levels by treatment group and visit.', 'unitOfMeasure': 'mE/qL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '159.18', 'spread': '19.18', 'groupId': 'OG000'}, {'value': '166.07', 'spread': '35.98', 'groupId': 'OG001'}, {'value': '179.60', 'spread': '37.43', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '156.93', 'spread': '22.57', 'groupId': 'OG000'}, {'value': '162.93', 'spread': '22.57', 'groupId': 'OG001'}, {'value': '177.33', 'spread': '36.76', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.50', 'spread': '12.61', 'groupId': 'OG000'}, {'value': '-2.40', 'spread': '15.87', 'groupId': 'OG001'}, {'value': '-11.44', 'spread': '31.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Total cholesterol blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - HDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.09', 'spread': '12.31', 'groupId': 'OG000'}, {'value': '45.50', 'spread': '14.43', 'groupId': 'OG001'}, {'value': '41.14', 'spread': '10.17', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '44.31', 'spread': '14.07', 'groupId': 'OG000'}, {'value': '43.64', 'spread': '11.62', 'groupId': 'OG001'}, {'value': '41.42', 'spread': '10.75', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.70', 'spread': '6.31', 'groupId': 'OG000'}, {'value': '2.11', 'spread': '3.69', 'groupId': 'OG001'}, {'value': '-1.67', 'spread': '4.50', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'High-density lipoprotein (HDL) blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant data from Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - LDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.36', 'spread': '25.02', 'groupId': 'OG000'}, {'value': '91.25', 'spread': '20.42', 'groupId': 'OG001'}, {'value': '105.79', 'spread': '37.30', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.92', 'spread': '28.72', 'groupId': 'OG000'}, {'value': '92.29', 'spread': '19.51', 'groupId': 'OG001'}, {'value': '103.73', 'spread': '33.32', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.60', 'spread': '11.58', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '14.92', 'groupId': 'OG001'}, {'value': '-13.00', 'spread': '26.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Low-density lipoprotein (LDL) blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124.55', 'spread': '60.32', 'groupId': 'OG000'}, {'value': '155.20', 'spread': '118.82', 'groupId': 'OG001'}, {'value': '163.47', 'spread': '102.54', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '124.79', 'spread': '69.57', 'groupId': 'OG000'}, {'value': '142.29', 'spread': '99.53', 'groupId': 'OG001'}, {'value': '162.17', 'spread': '102.74', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.00', 'spread': '40.14', 'groupId': 'OG000'}, {'value': '-39.30', 'spread': '77.44', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '49.85', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Triglyceride blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - VLDL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '24.73', 'spread': '12.04', 'groupId': 'OG000'}, {'value': '22.00', 'spread': '10.49', 'groupId': 'OG001'}, {'value': '33.17', 'spread': '22.59', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.75', 'spread': '13.93', 'groupId': 'OG000'}, {'value': '23.62', 'spread': '9.50', 'groupId': 'OG001'}, {'value': '28.00', 'spread': '14.04', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.80', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '-3.13', 'spread': '6.31', 'groupId': 'OG001'}, {'value': '-0.43', 'spread': '11.19', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Very low density lipoprotein (VLDL) blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '108.07', 'spread': '47.12', 'groupId': 'OG000'}, {'value': '98.61', 'spread': '15.50', 'groupId': 'OG001'}, {'value': '103.00', 'spread': '21.86', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '99.67', 'spread': '19.53', 'groupId': 'OG000'}, {'value': '102.13', 'spread': '18.13', 'groupId': 'OG001'}, {'value': '112.31', 'spread': '33.36', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.23', 'spread': '30.91', 'groupId': 'OG000'}, {'value': '2.00', 'spread': '20.64', 'groupId': 'OG001'}, {'value': '9.77', 'spread': '16.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Glucose blood levels by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Albumin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.39', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '4.35', 'spread': '0.30', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.38', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '4.23', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '4.37', 'spread': '0.32', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.03', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.20', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Albumin blood levels by treatment group and visit.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Globulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.72', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '2.81', 'spread': '0.42', 'groupId': 'OG001'}, {'value': '2.82', 'spread': '0.37', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.58', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '0.51', 'groupId': 'OG001'}, {'value': '2.78', 'spread': '0.38', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '-0.18', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Globulin blood levels by treatment group and visit.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant lab data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - A/G Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.65', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '1.58', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '1.57', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.31', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '0.07', 'spread': '0.12', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant date for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Bilirubin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.29', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.26', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.49', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '0.39', 'spread': '0.24', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.23', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Bilirubin blood level by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.10', 'spread': '0.32', 'groupId': 'OG000'}, {'value': '7.07', 'spread': '0.41', 'groupId': 'OG001'}, {'value': '7.17', 'spread': '0.40', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.14', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '6.92', 'spread': '0.45', 'groupId': 'OG001'}, {'value': '7.15', 'spread': '0.42', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.34', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.37', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Protein blood level by treatment group and visit.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Laboratory Measures - BUN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Evaluation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.80', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '10.74', 'spread': '3.18', 'groupId': 'OG001'}, {'value': '11.95', 'spread': '4.10', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.73', 'spread': '4.85', 'groupId': 'OG000'}, {'value': '11.55', 'spread': '3.41', 'groupId': 'OG001'}, {'value': '12.00', 'spread': '4.76', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '2.82', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '3.07', 'groupId': 'OG001'}, {'value': '-0.06', 'spread': '3.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'BUN blood level by treatment group and visit.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Available participant data for Evaluation and Week 6.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Abdominal Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Anorexia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Bruising Easily', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Diarrhea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Dizziness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '30.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Dry Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Dry Mouth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Enuresis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Excessive Tearing of the Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Fever', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Headache', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Hyperhydrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Hypersalivation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Malaise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Mucosal Ulceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Nasal Irritation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}, {'value': '23.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "nasal irritation" data.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Nausea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Rash', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Restlessness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Sedation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Sore Throat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '5.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '10.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Tinnitus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '10.5', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Tremor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Urticaria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '15.0', 'groupId': 'OG001'}, {'value': '15.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Uterine Contractions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Female participants'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '10.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Weight Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}, {'value': '25.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment.'}, {'type': 'SECONDARY', 'title': 'Side Effect Checklist (SEC) - Wheezing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}, {'value': '11.8', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety data for 56 participants exposed to study treatment minus 6 participants with missing "wheezing" data.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Composite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '25.9', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '9.7', 'groupId': 'OG001'}, {'value': '28.2', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '28.2', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '26.2', 'spread': '11.1', 'groupId': 'OG001'}, {'value': '28.9', 'spread': '11.8', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '2.3', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '0.7', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Attention Vigilance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '36.9', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '37.2', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '39.5', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '34.5', 'spread': '13.6', 'groupId': 'OG001'}, {'value': '35.1', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '2.6', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '6.9', 'groupId': 'OG001'}, {'value': '-2.1', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.\n\n.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Processing Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '33.5', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '31.9', 'spread': '11.7', 'groupId': 'OG001'}, {'value': '34.0', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '34.2', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '35.4', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '35.6', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '0.7', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '39.7', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '41.4', 'spread': '8.4', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '40.7', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '42.9', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '41.7', 'spread': '9.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.1', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '10.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Social Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '31.7', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '30.4', 'spread': '10.1', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '32.5', 'spread': '13.0', 'groupId': 'OG000'}, {'value': '29.6', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '32.8', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '0.8', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '7.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Verbal Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '36.3', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '36.5', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '38.7', 'spread': '9.9', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '36.4', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '-0.1', 'spread': '7.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Visual Learning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '33.8', 'spread': '14.3', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '35.1', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '36.2', 'spread': '16.6', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '34.2', 'spread': '10.3', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '2.4', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '-0.9', 'spread': '7.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Neurocognitive Assessment Battery (MCCB) - Working Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '34.7', 'spread': '10.7', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '35.3', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '34.8', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '34.7', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '38.1', 'spread': '11.7', 'groupId': 'OG002'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '0.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '2.8', 'spread': '6.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Positive and Negative Affect Schedule (PANAS) - Negative', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '20.5', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '18.2', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '8.6', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '18.8', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '18.0', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '18.9', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '6.8', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '5.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Positive and Negative Affect Schedule (PANAS) - Positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '38.1', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '42.5', 'spread': '8.9', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '38.5', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '39.5', 'spread': '12.3', 'groupId': 'OG001'}, {'value': '40.8', 'spread': '9.6', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'categories': [{'measurements': [{'value': '0.4', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '-1.6', 'spread': '11.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Reactions to Partner', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '13.7', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '5.6', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '13.7', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '12.5', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'categories': [{'measurements': [{'value': '0.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.'}, {'type': 'SECONDARY', 'title': 'Willingness to Interact', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '1: Oxytocin', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'OG001', 'title': '2: Galantamine', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'classes': [{'title': 'Treatment Week 0', 'categories': [{'measurements': [{'value': '23.67', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '23.18', 'spread': '4.22', 'groupId': 'OG001'}, {'value': '24.41', 'spread': '4.33', 'groupId': 'OG002'}]}]}, {'title': 'Treatment Week 6', 'categories': [{'measurements': [{'value': '24.47', 'spread': '3.31', 'groupId': 'OG000'}, {'value': '24.24', 'spread': '4.34', 'groupId': 'OG001'}, {'value': '25.00', 'spread': '4.29', 'groupId': 'OG002'}]}]}, {'title': 'Change from Week 0 at Week 6', 'categories': [{'measurements': [{'value': '0.80', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '0.59', 'spread': '4.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1: Oxytocin/Placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine'}, {'id': 'FG001', 'title': '2: Galantamine/Placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin'}, {'id': 'FG002', 'title': '3: Placebo-galantamine /Placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Withdrawn Prior to Study Drug Exposure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Exposed to Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'Consented/Screened for Study-- N=86\n\nWithdrew prior to randomization (N=28)\n\n* 2 withdrew consent\n* 26 did not meet inclusion criteria\n\nRandomized-- N=58'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '1: Oxytocin', 'description': 'Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks'}, {'id': 'BG001', 'title': '2: Galantamine', 'description': 'Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.'}, {'id': 'BG002', 'title': '3: Placebo', 'description': 'Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '11.7', 'groupId': 'BG002'}, {'value': '44.9', 'spread': '11.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Number of participants randomized N=58\n\nWithdrawn prior to exposure to study drug (N=2) Oxytocin N=1 withdrawn due to abnormal EKG Placebo N=1 Participant withdrew consent\n\nExposed to study drug N=56'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-10', 'studyFirstSubmitDate': '2009-04-28', 'resultsFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-02', 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scale for the Assessment of Negative Symptoms (SANS) Total Score', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.'}, {'measure': 'Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': '\\* Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Scale for the Assessment of Negative Symptoms (SANS) - Avolition', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS) - Alogia', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.'}, {'measure': 'Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome.'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS) - Total Score', 'timeFrame': 'Every other week for 6 weeks', 'description': 'The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.'}, {'measure': 'Brief Psychiatric Rating Scale (BPRS) - Psychosis Score', 'timeFrame': 'Every other week for 6 weeks', 'description': 'The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.'}, {'measure': 'Calgary Depression Scale (CDS) - Total Score', 'timeFrame': 'Every other week for 6 weeks', 'description': 'Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.'}, {'measure': 'Arizona Sexual Experience Questionnaire (ASEX) Female', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.'}, {'measure': 'Arizona Sexual Experience Questionnaire (ASEX) Male', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences.'}, {'measure': 'Vital Signs - Diastolic Blood Pressure', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean diastolic blood pressure by treatment and follow-up week'}, {'measure': 'Vital Signs - Systolic Blood Pressure', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean systolic blood pressure by treatment and follow-up week'}, {'measure': 'Vital Signs - Weight', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean weight (kg) by treatment and follow-up week'}, {'measure': 'Vital Signs - Pulse', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Mean sitting pulse (bpm) by treatment and follow-up week'}, {'measure': 'Simpson-Angus Scale (SAS)', 'timeFrame': 'Baseline, week 3, and week 6', 'description': 'SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating.'}, {'measure': 'Abnormal Involuntary Movement Scale (AIMS)', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating.'}, {'measure': 'Electrocardiogram (EKG)', 'timeFrame': 'Once during Evaluation and once at Treatment Week 6', 'description': 'Mean corrected QT interval (QTc) by study week and treatment.'}, {'measure': 'Barnes Akathisia Scale (BAS) - Global Score', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia.'}, {'measure': 'Blood Oxytocin Levels', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Blood Oxytocin Levels by Treatment and Visit'}, {'measure': 'Laboratory Measures - ALT/SGPT', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - AST/SGOT', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Alkaline Phosphatase', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Alkaline phosphatase blood level by treatment group and visit.'}, {'measure': 'Laboratory Measures - Calcium', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Calcium blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Sodium', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Sodium blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Potassium', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Potassium blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Chloride', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Chloride blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - CO2', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Carbon Dioxide (CO2) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Cholesterol', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Total cholesterol blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - HDL', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'High-density lipoprotein (HDL) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - LDL', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Low-density lipoprotein (LDL) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Triglycerides', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Triglyceride blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - VLDL', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Very low density lipoprotein (VLDL) blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Glucose', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Glucose blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Albumin', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Albumin blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - Globulin', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Globulin blood levels by treatment group and visit.'}, {'measure': 'Laboratory Measures - A/G Ratio', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Albumin to Globulin (A/G) ratio in the blood by treatment group and visit.'}, {'measure': 'Laboratory Measures - Bilirubin', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Bilirubin blood level by treatment group and visit.'}, {'measure': 'Laboratory Measures - Protein', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'Protein blood level by treatment group and visit.'}, {'measure': 'Laboratory Measures - BUN', 'timeFrame': 'Once during evaluation and once at the end of 6 weeks of study treatment', 'description': 'BUN blood level by treatment group and visit.'}, {'measure': 'Side Effect Checklist (SEC) - Abdominal Pain', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Anorexia', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Bruising Easily', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Constipation', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Diarrhea', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Dizziness', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Dry Eye', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Dry Mouth', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Enuresis', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Excessive Tearing of the Eye', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Fever', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Headache', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Hyperhydrosis', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Hypersalivation', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Insomnia', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Malaise', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Mucosal Ulceration', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Nasal Irritation', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Nausea', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Rash', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Restlessness', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Sedation', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Sore Throat', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Stiffness', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Tinnitus', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Tremor', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Urticaria', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Uterine Contractions', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Vomiting', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Weight Loss', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group.'}, {'measure': 'Side Effect Checklist (SEC) - Wheezing', 'timeFrame': 'Weekly for 6 weeks', 'description': 'Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Composite Score', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Attention Vigilance', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome.\n\n.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Processing Speed', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Social Cognition', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Verbal Learning', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Visual Learning', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Neurocognitive Assessment Battery (MCCB) - Working Memory', 'timeFrame': 'Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment).', 'description': 'MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome.'}, {'measure': 'Positive and Negative Affect Schedule (PANAS) - Negative', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays.'}, {'measure': 'Positive and Negative Affect Schedule (PANAS) - Positive', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays.'}, {'measure': 'Reactions to Partner', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner.'}, {'measure': 'Willingness to Interact', 'timeFrame': 'Treatment Week 0 and Week 6', 'description': 'Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Schizophrenia, oxytocin, galantamine'], 'conditions': ['Schizophrenia']}, 'descriptionModule': {'briefSummary': 'The project is designed to address the following two primary aims:\n\n1. To determine whether adjunctive oxytocin is superior to placebo for the treatment of persistent negative symptoms, as measured by the SANS total score, in people with schizophrenia.\n2. To determine whether adjunctive Galantamine is superior to placebo for the treatment of cognitive impairments, as measured by improvement on a composite neurocognitive score in people with schizophrenia.\n\nThe investigators will also address the following secondary aims:\n\n1. To determine whether people with schizophrenia treated with adjunctive oxytocin, compared to placebo, will show greater improvement on markers of negative symptom liability including: social affiliation, facial affect recognition, olfactory discrimination, initiation of smooth pursuit and latency of internally-driven saccades.\n2. To determine whether people with schizophrenia treated with adjunctive Galantamine, compared to placebo, will show greater improvement on markers of cognitive impairment liability including: predictive pursuit, P50 sensory gating and visual-spatial working memory.\n\nThe investigators will address the following exploratory aims:\n\n1. To determine whether changes in markers of negative symptom liability are correlated with changes in SANS total score.\n2. To determine whether changes in markers of cognitive impairment liability are correlated with changes in the composite neurocognitive score.\n3. To determine the response to oxytocin of all cognition domains assessed by the MATRICS battery, and to determine the response to Galantamine of all cognition domains assessed by the MATRICS, which are not included in the primary neurocognitive outcome score.\n4. To determine whether there is a differential response of oxytocin and Galantamine on the SANS total score, composite neurocognitive score, and with the phenotypic measures of negative symptom and cognitive impairment liability.\n5. To determine whether oxytocin and Galantamine are associated with:\n\n * adverse effects on positive or depressive symptoms;\n * adverse effects on motor symptoms;\n * adverse effects on laboratory and EKG measures;\n * increased occurrence of side effects;\n * social interest that is independent of sexual desire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any race\n* Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder\n* Judged clinically stable and will not exceed threshold levels of positive, depressive, and/or extrapyramidal symptoms\n* The minimum level of negative symptoms will be defined as follows:\n\n * Scale for the Assessment of Negative Symptoms (SANS) total score (minus the global items, and inappropriate affect, poverty of content of speech and attentional items) 20 or greater; OR\n * SANS alogia global item score 3 or greater\n* The maximum level of psychotic, depressive, and extrapyramidal symptoms at the beginning and end of leading in:\n\n * Brief Psychiatric Rating Scale (BPRS) psychotic factor score (4-items) less or equal to 16\n * BPRS Anxiety/Depression factor score (4-items) less than or equal to 14\n * Simpson-Angus-Scale (SAS) total score (13-items) less than or equal to 10\n* Subjects will be required to be on the same antipsychotic(s) for two months and on the same dose for the last month\n\nExclusion Criteria:\n\n* Participants with an organic brain disorder; mental retardation; or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol\n* Participants with intermittent alcohol or substance use will not be excluded unless they have met DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month.\n* Participants may be treated with one or more antipsychotics, except chlorpromazine, thioridazine, or mesoridazine. These latter antipsychotics are excluded because of the concern that their anticholinergic properties may interfere with the accurate assessment of galantamine efficacy.\n* Participants may not be treated with anticholinergic medications or have clinically significant extrapyramidal symptoms. Additionally, subjects treated with glycopyrrolate will be accepted.\n* Female participants may not be pregnant\n* Female subjects may not be taking olanzapine at doses higher than 30 mg . Male subjects may not be taking olanzapine at doses higher than 40 mg.'}, 'identificationModule': {'nctId': 'NCT01012167', 'acronym': 'CIDAR-3', 'briefTitle': 'Oxytocin or Galantamine Versus Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Oxytocin or Galantamine vs. Placebo for the Treatment of Negative Symptoms and Cognitive Impairments in Schizophrenia', 'orgStudyIdInfo': {'id': 'HP-00044324'}, 'secondaryIdInfos': [{'id': '1P50MH082999-01', 'link': 'https://reporter.nih.gov/quickSearch/1P50MH082999-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1: galantamine/placebo-oxytocin', 'description': 'Subjects randomized to galantamine will receive galantamine and placebo-oxytocin', 'interventionNames': ['Drug: Galantamine', 'Other: Placebo-Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: oxytocin/placebo-galantamine', 'description': 'Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine', 'interventionNames': ['Drug: Oxytocin', 'Other: Placebo-Galantamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3: placebo-galantamine /placebo-oxytocin', 'description': 'Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin', 'interventionNames': ['Other: Placebo-Oxytocin', 'Other: Placebo-Galantamine']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin: 24 IU in the morning and 24 IU in the evening given by nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration', 'armGroupLabels': ['2: oxytocin/placebo-galantamine']}, {'name': 'Galantamine', 'type': 'DRUG', 'description': 'Galantamine: 4 mg twice a day for 1 week, then 8 mg twice a day for 1 week, then 12 mg twice a day for 4 weeks', 'armGroupLabels': ['1: galantamine/placebo-oxytocin']}, {'name': 'Placebo-Oxytocin', 'type': 'OTHER', 'description': 'Saline nasal spray with a total of 6 puffs of the spray, 3 in each nostril at each administration', 'armGroupLabels': ['1: galantamine/placebo-oxytocin', '3: placebo-galantamine /placebo-oxytocin']}, {'name': 'Placebo-Galantamine', 'type': 'OTHER', 'description': 'Placebo tablets twice a day for 6 weeks', 'armGroupLabels': ['2: oxytocin/placebo-galantamine', '3: placebo-galantamine /placebo-oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Community Mental Health Centers', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21222', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Keypoint Community Mental Health Centers', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Psychiatric Research Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21228', 'city': 'Catonsville', 'state': 'Maryland', 'country': 'United States', 'facility': 'Maryland Psychiatric Research Center', 'geoPoint': {'lat': 39.27205, 'lon': -76.73192}}, {'zip': '21222', 'city': 'Dundalk', 'state': 'Maryland', 'country': 'United States', 'facility': 'Keypoint Mental health Center', 'geoPoint': {'lat': 39.25066, 'lon': -76.52052}}], 'overallOfficials': [{'name': 'William T Carpenter, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maryland Psychiatric Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Maryland Psychiatric Research Center, Outpatient Research Program', 'investigatorFullName': 'Robert Buchanan', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}