Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:34 PM
Study NCT ID:
NCT01624194
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2012-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hardanay@stanford.edu', 'phone': '(650) 736-1235', 'title': 'Antonio Y. Hardan, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The final sample was 84% male and was not powered to detect sex differences in treatment response. Participants were permitted to take other medications during the intervention. Many of our outcome measures relied on parent report.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 12, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cold Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Excitement/Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressive Affect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Labile Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Silly Behavior', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'More Distractible', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mouth Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intranasal Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Runny Nose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blinking Eyes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Earache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Loose Stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin Cut', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.73', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '3.18', 'spread': '2.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0275', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'General Linear Model (GLM)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Cold Symptoms', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Excitement/Agitation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Depressive Affect', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Labile Mood', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Silly Behavior', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'More Distractible', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Congestion', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Epistaxis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Sneezing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Mouth Pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intranasal Swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Runny Nose', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Blinking Eyes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Earache', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Nasal Discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Loose Stool', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Stomach Discomfort', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Skin Cut', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': "Fisher's Exact Test was used to test for differences in adverse events between oxytocin-treated and placebo-treated individuals. A p-value of ≤0.05 would have been statistically significant.", 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Week 4', 'description': 'Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Height.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '126', 'upperLimit': '141'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '135'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000', 'lowerLimit': '127', 'upperLimit': '142'}, {'value': '129', 'groupId': 'OG001', 'lowerLimit': '122', 'upperLimit': '136'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A mixed-models analysis was used to compare between groups, and between baseline and Week 4.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'cm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Clinical Global Impression-Improvement (CGI-I) Score at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Very Much Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Much Improved', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Minimally Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Very Much Worse', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 4', 'description': 'This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included.'}, {'type': 'SECONDARY', 'title': 'Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline Irritablity', 'categories': [{'measurements': [{'value': '13.20', 'spread': '11.91', 'groupId': 'OG000'}, {'value': '13.94', 'spread': '8.71', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Irritability', 'categories': [{'measurements': [{'value': '8.86', 'spread': '8.87', 'groupId': 'OG000'}, {'value': '11.78', 'spread': '8.11', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Lethargy', 'categories': [{'measurements': [{'value': '14.13', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '8.34', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Lethargy', 'categories': [{'measurements': [{'value': '10.6', 'spread': '4.07', 'groupId': 'OG000'}, {'value': '7.33', 'spread': '6.30', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Stereotypy', 'categories': [{'measurements': [{'value': '5.69', 'spread': '6.20', 'groupId': 'OG000'}, {'value': '5.61', 'spread': '4.55', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Stereotypy', 'categories': [{'measurements': [{'value': '4.86', 'spread': '5.07', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '4.85', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Hyperactivity', 'categories': [{'measurements': [{'value': '15.00', 'spread': '13.74', 'groupId': 'OG000'}, {'value': '23.28', 'spread': '10.74', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Hyperactivity', 'categories': [{'measurements': [{'value': '10.50', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '19.11', 'spread': '9.68', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Inappropriate Speech', 'categories': [{'measurements': [{'value': '3.94', 'spread': '3.28', 'groupId': 'OG000'}, {'value': '5.44', 'spread': '3.99', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Inappropriate Speech', 'categories': [{'measurements': [{'value': '2.86', 'spread': '3.23', 'groupId': 'OG000'}, {'value': '4.17', 'spread': '3.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.66', 'spread': '3.05', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3395', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'General Linear Model (GLM)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed the protocol are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline Social Standard Score', 'categories': [{'measurements': [{'value': '61.4', 'spread': '12.82', 'groupId': 'OG000'}, {'value': '67.75', 'spread': '12.45', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Social Standard Score', 'categories': [{'measurements': [{'value': '66.11', 'spread': '16.03', 'groupId': 'OG000'}, {'value': '70.92', 'spread': '14.23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Communication Standard Scores', 'categories': [{'measurements': [{'value': '66.91', 'spread': '19.60', 'groupId': 'OG000'}, {'value': '71.80', 'spread': '17.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Communication Standard Scores', 'categories': [{'measurements': [{'value': '71.33', 'spread': '11.43', 'groupId': 'OG000'}, {'value': '78.29', 'spread': '19.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'timeFrame': 'Up to 4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'timeFrame': 'Baseline; Week 4', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'timeFrame': 'Up to 4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not not collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'timeFrame': 'Up to 4 weeks', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not not collected for this outcome.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline Affect Recognition Score', 'categories': [{'measurements': [{'value': '10', 'spread': '1.89', 'groupId': 'OG000'}, {'value': '9.43', 'spread': '3.78', 'groupId': 'OG001'}]}]}, {'title': 'Week 4 Affect Recognition Score', 'categories': [{'measurements': [{'value': '8.75', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '4.08', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.\n\nScores can range from 1 to 19.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data were included.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma Oxytocin Levels During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.82', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '8.66', 'spread': '3.85', 'groupId': 'OG001'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '10.36', 'spread': '3.57', 'groupId': 'OG000'}, {'value': '8.40', 'spread': '3.57', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4 weeks', 'description': 'This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study.\n\nThere are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.68', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '5.79', 'spread': '2.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9757', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'General Linear Model (GLM)', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Only analyzed after 4 weeks.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '39.5'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '33.2'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '33.5', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '40.4'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '23.9', 'upperLimit': '33.7'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'A mixed-models analysis was used to compare between groups, and between baseline and Week 4.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'kilograms', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline Sitting Heart Rate', 'categories': [{'measurements': [{'value': '92.5', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '101.9'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '83.6', 'upperLimit': '101.8'}]}]}, {'title': 'Post 4 -Week Sitting Heart Rate', 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '106.5'}, {'value': '101.6', 'groupId': 'OG001', 'lowerLimit': '92.5', 'upperLimit': '110.6'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'beats per minute', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'OG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'classes': [{'title': 'Baseline Systolic Blood Pressure, Sitting', 'categories': [{'measurements': [{'value': '104.2', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '109.8'}, {'value': '101.0', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '106.4'}]}]}, {'title': 'Post 4 -Week Systolic Blood Pressure, Sitting', 'categories': [{'measurements': [{'value': '111.1', 'groupId': 'OG000', 'lowerLimit': '105.5', 'upperLimit': '116.6'}, {'value': '110.9', 'groupId': 'OG001', 'lowerLimit': '105.6', 'upperLimit': '116.3'}]}]}, {'title': 'Baseline Diastolic Blood Pressure, Sitting', 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '69.6'}, {'value': '64.6', 'groupId': 'OG001', 'lowerLimit': '59.4', 'upperLimit': '69.7'}]}]}, {'title': 'Post 4 -Week Diastolic Blood Pressure, Sitting', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '66.1', 'upperLimit': '76.7'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '63.8', 'upperLimit': '74.1'}]}]}, {'title': 'Baseline Systolic Blood Pressure, Standing', 'categories': [{'measurements': [{'value': '101.6', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '108.1'}, {'value': '107.7', 'groupId': 'OG001', 'lowerLimit': '101.5', 'upperLimit': '113.9'}]}]}, {'title': 'Post 4 -Week Systolic Blood Pressure, Standing', 'categories': [{'measurements': [{'value': '111.6', 'groupId': 'OG000', 'lowerLimit': '105.2', 'upperLimit': '118.1'}, {'value': '105.6', 'groupId': 'OG001', 'lowerLimit': '99.4', 'upperLimit': '111.9'}]}]}, {'title': 'Baseline Diastolic Blood Pressure, Standing', 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '68.6'}, {'value': '68.2', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '73.3'}]}]}, {'title': 'Post 4 -Week Diastolic Blood Pressure, Standing', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000', 'lowerLimit': '65.6', 'upperLimit': '76.2'}, {'value': '69.8', 'groupId': 'OG001', 'lowerLimit': '64.7', 'upperLimit': '74.9'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'For all blood pressure analyses.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline; Week 4', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with available data are included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU twice daily (BID) (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'FG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted in the Autism and Developmental Disabilities Clinic in the Division of Child and Adolescent Psychiatry at Stanford University. Recruitment began in June 2012 and ended in April 2016.\n\nParticipants were recruited through the Stanford Autism Research Registry, flyers posted in the community, posted online and special events.', 'preAssignmentDetails': '54 subjects were consented and assessed for eligibility. 19 subjects were excluded (13 did not meet inclusion criteria and 6 declined to participate). Additionally, 1 subject allocated to oxytocin did not receive allocated intervention due to parent declining to participate.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin Nasal Spray', 'description': 'Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice for 4-weeks.'}, {'id': 'BG001', 'title': 'Placebo Nasal Spray', 'description': 'Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, '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': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2012-06-18', 'resultsFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-03', 'studyFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Parent Rated Social Responsiveness Scale (SRS) Scores During Treatment.', 'timeFrame': 'Baseline; Week 4', 'description': 'Social Responsiveness Scale (SRS) raw scores measure social abilities with lower raw scores meaning better social abilities. (Raw Score Range: 0 - 195)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Side Effects Assessed Using Parent Rated Dosage Record Treatment Emergent Symptom Scale (DOTES) Scores During Treatment', 'timeFrame': 'Baseline through Week 4', 'description': 'Dosage Record Treatment Emergent Symptom Scale (DOTES) side effects reported by parents during 4-weeks of treatment. Participant Counts are used.'}, {'measure': 'Change From Baseline in Height.', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I) Score at Week 4', 'timeFrame': 'Baseline to Week 4', 'description': 'This outcome is reported as the count of participants in each CGI-I rating category at the week 4 visit, assessing change over the 4-week period. CGI-I rating of 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No Change, 5=Minimally Worse, 6=Much Worse, and 7=Very Much Worse.'}, {'measure': 'Parent Rated Aberrant Behavior Checklist (ABC) Irritability Scores at Baseline and Week 4', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher scores indicate more symptoms, lower scores indicate fewer symptoms. Irritability scores can range from 0-45. Lethargy scores can range from 0-48. Stereotypy scores can range from 0-21. Hyperactivity scores can range from 0-48. Inappropriate speech scores can from 0-12.'}, {'measure': "Change From Baseline in Parent Rated Spence Children's Anxiety Scale (SCAS) During Treatment.", 'timeFrame': 'Baseline; Week 4', 'description': 'Scale measuring severity of anxiety symptoms. Higher scores mean higher levels of anxiety, lower scores mean lower levels of anxiety. (Raw Score Range: 0 - 114)'}, {'measure': 'Change From Baseline in Vineland Adaptive Behavior Scales, Second Edition - Social and Communication Subscales During Treatment.', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher Social Standard Score means better social skills, lower Social Standard Score means worse social skills. Higher Communication Standard Score means better communication skills, lower Communication Standard Score means worse communication skills. Standard Scores can range from 20 to 160.'}, {'measure': 'Change From Baseline in Laboratory Based Facial Emotion Recognition Abilities During Treatment.', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Change From Baseline in Laboratory Based Eye-gaze to Social Cues During Treatment.', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Change From Baseline in Reading the Mind in the Eyes Test, Child Version (RMET-child) Scores During Treatment.', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Change From Baseline in Laboratory Based Social Mimicry Abilities During Treatment.', 'timeFrame': 'Up to 4 weeks'}, {'measure': 'Change From Baseline in Developmental NEuroPSYchological Assessment (NEPSY-II) Affect Recognition Scores During Treatment.', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher Affect Recognition scores mean better affect recognition abilities, lower Affect Recognition scores mean worse affect recognition abilities.\n\nScores can range from 1 to 19.'}, {'measure': 'Change From Baseline in Plasma Oxytocin Levels During Treatment.', 'timeFrame': 'Up to 4 weeks', 'description': 'This outcome originally specified that oxytocin, vasopressin, and cortisol levels would be assessed; however, data on vasopressin and cortisol levels were not collected during the study.\n\nThere are no clinical laboratory tests that establish a normative range for oxytocin. Measurements prior to and following treatment were intended to evaluate oxytocin level as a predictor of response.'}, {'measure': 'Change From Baseline in Parent Rated Repetitive Behavior Scale- Revised (RBS-R) Scores During Treatment.', 'timeFrame': 'Baseline; Week 4', 'description': 'Higher scores on the Repetitive Behavior Scale- Revised mean higher levels of repetitive and restricted behaviors. (Raw Score Total Range: 0 - 129)'}, {'measure': 'Change From Baseline in Weight', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Change From Baseline in Heart Rate', 'timeFrame': 'Baseline; Week 4'}, {'measure': 'Change From Baseline in Blood Pressure', 'timeFrame': 'Baseline; Week 4'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Autism']}, 'referencesModule': {'references': [{'pmid': '28696286', 'type': 'RESULT', 'citation': 'Parker KJ, Oztan O, Libove RA, Sumiyoshi RD, Jackson LP, Karhson DS, Summers JE, Hinman KE, Motonaga KS, Phillips JM, Carson DS, Garner JP, Hardan AY. Intranasal oxytocin treatment for social deficits and biomarkers of response in children with autism. Proc Natl Acad Sci U S A. 2017 Jul 25;114(30):8119-8124. doi: 10.1073/pnas.1705521114. Epub 2017 Jul 10.'}, {'pmid': '37811711', 'type': 'DERIVED', 'citation': 'Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.'}]}, 'descriptionModule': {'briefSummary': 'Autism is a pervasive developmental disorder characterized by core deficits in social behavior and communication, and the presence of repetitive or stereotyped behaviors. It is one of three recognized disorders in the autism spectrum which affects an estimated 1 in 88 children in the United States. At present, pharmacotherapies target only associated features of autism, with no effective drug treatments for the social impairments. Several lines of evidence now suggest that the neuropeptide oxytocin (OT) may be an effective treatment for the core social deficits in autism. Here we will test the effects of twice daily intranasal OT (24 IU) over a 4-week period for enhancing social deficits in male and female children aged 6-12 years with autism. This research has high potential to lead to the development of more effective treatments and earlier interventions for children with autism.', 'detailedDescription': 'In recent years, the neuropeptide oxytocin (OT) has been implicated in a wide range of social behaviors including attachment bonds, emotion recognition, eye gaze to social cues, and memory for social information. Social impairments represent one of the most intractable features of autism, and evidence now suggests that OT biology is dysregulated in individuals with this disorder. The central aim of the research outlined here is to test whether OT administration to children with autism increases their quality and quantity of social interactions and enhances their ability to process emotional and social information. Findings from initial single-dose OT administration studies in teenaged and adult males with autism have shown improvement in some aspects of social functioning, but replication and extension to well-controlled treatment trials with younger male and female subjects is necessary to evaluate effectiveness. We therefore aim to investigate the effect of intranasal OT on social cognition and behavior immediately following a single-dose (24IU) and following a 4-week period of OT (24IU BID) administration in a sample of 50 subjects with autism aged 6 to 12 years. The primary outcome for this study is change in social behavior, as determined by parent ratings on the Social Responsiveness Scale (SRS) after the 4-week treatment period. Secondary outcomes are changes in functioning on laboratory-based measures of social behavior and cognition following single-dose and 4-week OT administration. Research in a small study sample (N=13) also identified treatment responders and non-responders to a single-dose of OT. Thus, we also aim to identify biological and cognitive and behavioral variables (i.e., pretreatment levels of social functioning and pretreatment plasma hormone levels) that may influence treatment response efficacy in our larger study sample. On completion of the 4-week treatment period all subjects will have the option of participating in another 4-week double-blind trial in which they will be switched to the alternate nasal spray to that which they previously received. They will then undergo a fourth and final assessment time-point using the same testing procedures as outlined above on completion of the 4-week dosing. By providing subjects with the option of participating in a second 4-week treatment trial, all subjects will have an opportunity to receive the active oxytocin nasal spray. We also will be able to examine any ongoing effects of oxytocin treatment in the group receiving placebo during the second 4-week administration period. Subjects not willing to take part in the second trial will exit the study and will be referred to their treating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically healthy outpatients between 6 and 12 years of age (cut off 12 years and 11 months)\n* Intelligence Quotient \\> 40\n* Diagnosis of autism spectrum disorder based on the Autism Diagnostic Interview - Revised, Autism Diagnostic Observation Schedule, and DSM-IV criteria\n* Clinical Global Impression severity rating of 4 or higher\n* Care provider who can reliably bring subject to clinic visits, provide trustworthy ratings, and interacts with the subject on a regular basis\n* Stable medications for at least 4 weeks\n* No planned changes in psychosocial interventions during the trial\n* Willingness to provide blood samples.\n\nExclusion Criteria:\n\n* Diagnostics and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder\n* Regular nasal obstruction or nosebleeds\n* Active medical problems: unstable seizures, significant physical illness (e.g., serious liver, renal, or cardiac pathology)\n* Sensitivity to preservatives (in particular E 216, E 218, and chlorobutanol hemihydrate)\n* A genetic abnormality (e.g., Fragile X Syndrome)\n* Significant hearing or vision impairments\n* Habitually drinks large volumes of water\n* Pregnancy, breastfeeding, or child birth within the last 6 months\n* Sexually active females not using a reliable method of contraception.'}, 'identificationModule': {'nctId': 'NCT01624194', 'briefTitle': 'Intranasal Oxytocin Treatment for Social Deficits in Children With Autism', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Double-blind, Randomized, Placebo Controlled Trial of Intranasal Oxytocin Treatment for Social Deficits in Children With Autism.', 'orgStudyIdInfo': {'id': 'SU-12132011-8827'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin nasal spray', 'description': 'Prior to randomization, all subjects will participate in a 1-week open-label placebo lead-in trial. Each subject will be administered the placebo nasal spray at Stanford University and then their parent will continue administering the nasal spray to the subject for 1 week at home. Each subject will then be randomly assigned either to the active group or to the placebo (stratified by gender) and will be given the appropriate nasal spray bottle and their parents will be responsible for administering 3 puffs per nostril (4 IU/puff) to their child for a total dose of 24 IU oxytocin or placebo twice daily (BID; morning and evening) for 4-weeks. On completion of this 4-week treatment trial subjects will have the option of participating in a second double-blind trial in which they will be assigned to the alternate nasal spray, to that which they received during the first 4-week trial, for an additional 4-week period.', 'interventionNames': ['Drug: Oxytocin nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo nasal spray', 'description': 'The placebo nasal spray bottles will be prepared by adding all of the ingredients used in the Syntocinon nasal sprays with the exception of the concentrated oxytocin solution.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin nasal spray', 'type': 'DRUG', 'otherNames': ['Syntocinon® Nasal Spray'], 'description': '24IU BID (3 x 0.1 mL \\[4IU\\] sprays per nostril twice daily for 4-weeks.', 'armGroupLabels': ['Oxytocin nasal spray']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 x 0.1 mL sprays per nostril twice daily for 4-weeks.', 'armGroupLabels': ['Placebo nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Antonio Y Hardan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Karen J Parker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Child Psychiatry', 'investigatorFullName': 'Antonio Hardan', 'investigatorAffiliation': 'Stanford University'}}}}