Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 4:31 PM
Study NCT ID:
NCT02671266
Status:
COMPLETED
Last Update Posted:
2018-11-23
First Post:
2016-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oxytocin Administration in BDD and OCD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}, {'id': 'D009771', 'term': 'Obsessive-Compulsive Disorder'}], 'ancestors': [{'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'afang@mgh.harvard.edu', 'phone': '617-643-7717', 'title': 'Dr. Angela Fang', 'organization': 'Massachusetts General Hospital/Harvard Medical School'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.', 'description': 'Adverse events data were collected by a nurse using a symptom checklist.', 'eventGroups': [{'id': 'EG000', 'title': 'Oxytocin', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 15, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 17, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Feeling drowsy or sleepy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Feeling of calmness or euphoria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty sitting still', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Trouble concentrating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety or depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth/throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor memory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremors or shakiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Emotion Recognition Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'OG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}], 'classes': [{'title': 'BDD oxytocin- self-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.67', 'spread': '3.16', 'groupId': 'OG000'}, {'value': '17.00', 'spread': '6.41', 'groupId': 'OG001'}]}]}, {'title': 'BDD placebo- self-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.00', 'spread': '3.64', 'groupId': 'OG000'}, {'value': '16.40', 'spread': '6.38', 'groupId': 'OG001'}]}]}, {'title': 'BDD oxytocin- other-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.00', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '18.30', 'spread': '6.77', 'groupId': 'OG001'}]}]}, {'title': 'BDD placebo- other-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.44', 'spread': '2.96', 'groupId': 'OG000'}, {'value': '16.40', 'spread': '6.15', 'groupId': 'OG001'}]}]}, {'title': 'HC oxytocin- self-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.67', 'spread': '6.00', 'groupId': 'OG000'}, {'value': '17.13', 'spread': '3.76', 'groupId': 'OG001'}]}]}, {'title': 'HC placebo- self-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.88', 'spread': '6.64', 'groupId': 'OG000'}, {'value': '18.88', 'spread': '3.83', 'groupId': 'OG001'}]}]}, {'title': 'HC oxytocin- other-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.78', 'spread': '5.74', 'groupId': 'OG000'}, {'value': '16.25', 'spread': '6.90', 'groupId': 'OG001'}]}]}, {'title': 'HC placebo- other-referent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.00', 'spread': '6.52', 'groupId': 'OG000'}, {'value': '17.88', 'spread': '3.36', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '45 minutes post nasal spray administration', 'description': 'This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for BDD and healthy control participants who completed at least one drug visit. There was one patient in the oxytocin first arm who did not complete second placebo drug visit. OCD group was excluded from analyses due to difficulties with recruitment.'}, {'type': 'SECONDARY', 'title': 'Interpretation Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'OG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}], 'classes': [{'title': 'Oxytocin BDD- BDD threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.88', 'spread': '8.51', 'groupId': 'OG000'}, {'value': '26.75', 'spread': '13.50', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin BDD- SA threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.25', 'spread': '4.06', 'groupId': 'OG000'}, {'value': '33.25', 'spread': '16.29', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin BDD- Gen threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.88', 'spread': '8.48', 'groupId': 'OG000'}, {'value': '22.38', 'spread': '6.46', 'groupId': 'OG001'}]}]}, {'title': 'Placebo BDD- BDD threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.88', 'spread': '10.03', 'groupId': 'OG000'}, {'value': '28.78', 'spread': '9.01', 'groupId': 'OG001'}]}]}, {'title': 'Placebo BDD- SA threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.75', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '31.11', 'spread': '6.37', 'groupId': 'OG001'}]}]}, {'title': 'Placebo BDD- Gen threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.88', 'spread': '8.13', 'groupId': 'OG000'}, {'value': '24.33', 'spread': '7.86', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin HC- BDD threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.13', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '8.50', 'spread': '9.09', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin HC- SA threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.38', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '12.90', 'spread': '9.58', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin HC- Gen threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.75', 'spread': '6.50', 'groupId': 'OG000'}, {'value': '15.38', 'spread': '9.13', 'groupId': 'OG001'}]}]}, {'title': 'Placebo HC- BDD threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.71', 'spread': '4.31', 'groupId': 'OG000'}, {'value': '7.88', 'spread': '5.59', 'groupId': 'OG001'}]}]}, {'title': 'Placebo HC- SA threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.86', 'spread': '5.11', 'groupId': 'OG000'}, {'value': '12.88', 'spread': '7.85', 'groupId': 'OG001'}]}]}, {'title': 'Placebo HC- Gen threat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.41', 'spread': '4.82', 'groupId': 'OG000'}, {'value': '13.63', 'spread': '8.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant (who received oxytocin first) misunderstood the IQ so was excluded from analysis. One subject who received oxytocin first missed the second placebo drug visit. Another subject who received placebo first accidentally did not receive the Interpretation Questionnaire due to administration error. OCD group was excluded from analysis.'}, {'type': 'SECONDARY', 'title': 'Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'OG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}], 'classes': [{'title': 'BDD Oxytocin Happy Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '636.56', 'spread': '66.07', 'groupId': 'OG000'}, {'value': '689.32', 'spread': '282.68', 'groupId': 'OG001'}]}]}, {'title': 'BDD Oxytocin Happy Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '624.08', 'spread': '78.21', 'groupId': 'OG000'}, {'value': '581.47', 'spread': '67.98', 'groupId': 'OG001'}]}]}, {'title': 'BDD Oxytocin Neutral Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '626.80', 'spread': '74.58', 'groupId': 'OG000'}, {'value': '594.96', 'spread': '92.18', 'groupId': 'OG001'}]}]}, {'title': 'BDD Oxytocin Neutral Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '649.77', 'spread': '65.46', 'groupId': 'OG000'}, {'value': '737.74', 'spread': '361.07', 'groupId': 'OG001'}]}]}, {'title': 'BDD Oxytocin Disgust Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '622.30', 'spread': '77.45', 'groupId': 'OG000'}, {'value': '607.09', 'spread': '111.39', 'groupId': 'OG001'}]}]}, {'title': 'BDD Oxytocin Disgust Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '674.00', 'spread': '95.03', 'groupId': 'OG000'}, {'value': '603.94', 'spread': '83.59', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Happy Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '587.86', 'spread': '57.84', 'groupId': 'OG000'}, {'value': '718.41', 'spread': '401.92', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Happy Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '627.45', 'spread': '106.07', 'groupId': 'OG000'}, {'value': '610.25', 'spread': '95.03', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Neutral Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '590.84', 'spread': '55.10', 'groupId': 'OG000'}, {'value': '604.59', 'spread': '62.14', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Neutral Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '626.99', 'spread': '116.93', 'groupId': 'OG000'}, {'value': '614.46', 'spread': '79.94', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Disgust Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '604.24', 'spread': '63.82', 'groupId': 'OG000'}, {'value': '601.19', 'spread': '66.31', 'groupId': 'OG001'}]}]}, {'title': 'BDD Placebo Disgust Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '593.57', 'spread': '52.72', 'groupId': 'OG000'}, {'value': '625.31', 'spread': '119.00', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Happy Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '622.08', 'spread': '75.20', 'groupId': 'OG000'}, {'value': '984.01', 'spread': '452.85', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Happy Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '634.15', 'spread': '80.27', 'groupId': 'OG000'}, {'value': '881.50', 'spread': '270.97', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Neutral Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '656.64', 'spread': '120.41', 'groupId': 'OG000'}, {'value': '871.63', 'spread': '336.02', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Neutral Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '644.85', 'spread': '137.26', 'groupId': 'OG000'}, {'value': '781.01', 'spread': '231.04', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Disgust Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '613.12', 'spread': '72.78', 'groupId': 'OG000'}, {'value': '834.81', 'spread': '219.30', 'groupId': 'OG001'}]}]}, {'title': 'HC Oxytocin Disgust Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '620.73', 'spread': '75.60', 'groupId': 'OG000'}, {'value': '826.90', 'spread': '208.97', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Happy Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '593.97', 'spread': '73.17', 'groupId': 'OG000'}, {'value': '811.25', 'spread': '200.97', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Happy Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '576.44', 'spread': '78.04', 'groupId': 'OG000'}, {'value': '919.46', 'spread': '268.07', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Neutral Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '575.38', 'spread': '108.46', 'groupId': 'OG000'}, {'value': '774.14', 'spread': '150.24', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Neutral Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '571.02', 'spread': '84.09', 'groupId': 'OG000'}, {'value': '847.44', 'spread': '182.60', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Disgust Disengagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '603.58', 'spread': '106.17', 'groupId': 'OG000'}, {'value': '896.73', 'spread': '238.16', 'groupId': 'OG001'}]}]}, {'title': 'HC Placebo Disgust Engagement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '560.64', 'spread': '52.51', 'groupId': 'OG000'}, {'value': '864.02', 'spread': '215.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data reported for BDD and HC participants who completed at least one drug visit. One HC patient in the oxytocin first arm did not complete second placebo visit. Another HC patient in the placebo first arm had missing data from the placebo visit due to administrative error. OCD group was excluded from analyses due to difficulties with recruitment.'}, {'type': 'SECONDARY', 'title': 'Amount of Initial Monetary Transfer During Trust Game', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'OG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}], 'classes': [{'title': 'Oxytocin BDD- Game 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.11', 'spread': '2.67', 'groupId': 'OG000'}, {'value': '7.67', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Placebo BDD- Game 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.11', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin BDD- Game 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.22', 'spread': '2.33', 'groupId': 'OG000'}, {'value': '6.89', 'spread': '3.51', 'groupId': 'OG001'}]}]}, {'title': 'Placebo BDD- Game 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.22', 'spread': '3.35', 'groupId': 'OG000'}, {'value': '8.00', 'spread': '2.50', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin HC- Game 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.25', 'spread': '2.49', 'groupId': 'OG000'}, {'value': '7.75', 'spread': '2.19', 'groupId': 'OG001'}]}]}, {'title': 'Placebo HC- Game 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.71', 'spread': '2.06', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '3.12', 'groupId': 'OG001'}]}]}, {'title': 'Oxytocin HC- Game 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.88', 'spread': '1.64', 'groupId': 'OG000'}, {'value': '6.88', 'spread': '2.75', 'groupId': 'OG001'}]}]}, {'title': 'Placebo HC- Game 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.29', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '3.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Sample includes BDD and healthy control participants who completed at least one drug visit. OCD group was excluded from analysis due to difficulties with recruitment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'FG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'BDD Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'OCD Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Healthy Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'BG001', 'title': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).\n\nOxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.\n\nPlacebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '27.20', 'spread': '8.90', 'groupId': 'BG000'}, {'value': '27.05', 'spread': '7.00', 'groupId': 'BG001'}, {'value': '27.12', 'spread': '7.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BDD-YBOCS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.11', 'spread': '5.13', 'groupId': 'BG000'}, {'value': '24.89', 'spread': '3.55', 'groupId': 'BG001'}, {'value': '24.89', 'spread': '4.19', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS) is a 12-item clinician administered measure that is designed to assess body dysmorphic disorder symptom severity. Total scores are reported. Total scores range from 0 (least severe) to 48 (most severe).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BDD-YBOCS was a clinician-administered measure only administered to patients with body dysmorphic disorder.'}, {'title': 'BABS', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '12.73', 'spread': '5.82', 'groupId': 'BG000'}, {'value': '11.17', 'spread': '3.41', 'groupId': 'BG001'}, {'value': '11.91', 'spread': '4.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Brown Assessment of Beliefs Scale (BABS) is a clinician-administered measure designed to assess degree of insight and conviction of beliefs. Total scores are reported. Total scores range from 0 (excellent insight) to 24 (lacks insight, delusional).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'BABS was a clinician-administered measure that was administered to patients with body dysmorphic disorder and obsessive compulsive disorder.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-08', 'size': 591790, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-07-16T15:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-21', 'studyFirstSubmitDate': '2016-01-12', 'resultsFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2016-02-01', 'lastUpdatePostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-21', 'studyFirstPostDateStruct': {'date': '2016-02-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Emotion Recognition Questionnaire', 'timeFrame': '45 minutes post nasal spray administration', 'description': 'This questionnaire includes 48 items for 2 conditions- a self-referent and other-referent condition. Scores are reported for each condition (self-referent or other-referent) reflecting the number of correct responses. Scores range from 0 (least accurate) to 24 (most accurate) for each condition of the questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Interpretation Questionnaire', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'This questionnaire includes 33 ambiguous scenarios, representing 3 conditions: BDD threat scenarios, social anxiety threat scenarios, and general threat scenarios. Each item involves 3 possible thoughts that may come to mind in the scenarios which reflect positive, negative, and neutral interpretations. Participants will be asked to rate the likelihood of having each of the thoughts on a scale of 0 (very unlikely) to 4 (very likely). Total scores are reported for negative threat interpretations for each of the 3 conditions (BDD threat, social anxiety threat, general threat), with scores ranging from 0 (very unlikely) to 44 (very likely).'}, {'measure': 'Engagement Towards and Disengagement From Threat Cues in a Spatial Cueing Task', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'The outcome measures are response latencies (in milliseconds) on engagement and disengagement trials for disgust, happy, and neutral cue types. Longer response latencies reflect more sustained attention.'}, {'measure': 'Amount of Initial Monetary Transfer During Trust Game', 'timeFrame': 'At least 45 minutes post nasal spray administration', 'description': 'Participants will have the decision of sending between 0 to 10 game dollars to another participant, without any expectation of monetary return. This initial investment amount will serve as a measure of trust, with a transfer of 0 game dollars indicating no trust and a transfer of 10 game dollars indicating maximum trust.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Oxytocin', 'Body dysmorphic disorder', 'Obsessive-compulsive disorder'], 'conditions': ['Body Dysmorphic Disorder', 'Obsessive-compulsive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to investigate the effect of an acute administration of intranasal oxytocin, relative to placebo, on social cognitive impairments among individuals with body dysmorphic disorder and obsessive-compulsive disorder, compared to healthy controls.', 'detailedDescription': 'Despite the development of efficacious pharmacologic and psychological treatments body dysmorphic disorder (BDD), treatment outcome data suggest that there is still considerable room for improvement. A closer examination of biological mechanisms underlying psychopathology may help uncover mechanisms to target during intervention and thereby provide a novel approach to treatment. Given that the neuropeptide, oxytocin, is involved in the regulation of a variety of social and cognitive dimensions, including emotion recognition and social attentional processing, there are direct implications regarding its role in the development of such deficits among individuals with BDD. The current study therefore aims to investigate the effect of oxytocin administration on social cognitive impairments in BDD and a related disorder, OCD. Twenty treatment-seeking male and female outpatients with BDD, 20 individuals with OCD, and 20 healthy participants will be assigned to receive an oxytocin and placebo nasal spray one week apart. During each visit, subjects will complete a series of tasks to measure emotion recognition, attentional biases, interpretive biases, and trust behavior. Importantly, these findings may show that a single administration of oxytocin may alter social cognitive processes thought to maintain BDD, and ultimately inform treatments for BDD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment-seeking adult males and females ≥ 18 years of age\n* Meets DSM-IV criteria for principal BDD (for BDD group) or principal OCD (for OCD group), as determined by Structured Clinical Interview for DSM-IV (SCID) diagnostic interview\n* For females only: must be taking low-dose oral contraceptive pills, as defined by monophasic pills containing \\<50 mcg ethinyl estradiol\n* For healthy volunteers only: does not meet current DSM-IV diagnosis of any Axis I disorder\n\nExclusion Criteria:\n\n* Participants in the BDD group will be excluded if they have a comorbid diagnosis of OCD and participants in the OCD group will be excluded if they have a comorbid diagnosis of BDD.\n* Current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, substance abuse or substance dependence. All other Axis I comorbidities will be permitted to foster the accrual of a clinically relevant sample.\n* Significant nasal pathology (e.g., atrophic rhinitis, history of hypophysectomy, recurrent nosebleeds)\n* Smokers who smoke ≥ 15 cigarettes daily\n* Serious medical illnesses\n* Active homicidal or suicidal ideation\n* Concurrent use of psychotropic medications\n* Steroid or hormone use (except low-dose oral contraceptive pills for females, which is allowed)\n* For females only: positive urine pregnancy test and use of high dose estrogen/progestin pills (low dose estrogen/progestin oral contraceptives will be allowed due to stability of hormone levels during active phase)\n* For healthy volunteers only: any current DSM-IV Axis I disorder'}, 'identificationModule': {'nctId': 'NCT02671266', 'briefTitle': 'Oxytocin Administration in BDD and OCD', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Intranasal Oxytocin on Social Cognition', 'orgStudyIdInfo': {'id': '2014P001777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin, Then Placebo', 'description': 'Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient).', 'interventionNames': ['Drug: Oxytocin', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, Then Oxytocin', 'description': 'Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril).', 'interventionNames': ['Drug: Oxytocin', 'Drug: Placebo']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Syntocinon (Novartis Switzerland)'], 'description': 'Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.', 'armGroupLabels': ['Oxytocin, Then Placebo', 'Placebo, Then Oxytocin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Matching placebo formulation'], 'description': 'Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.', 'armGroupLabels': ['Oxytocin, Then Placebo', 'Placebo, Then Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital/Harvard Medical School', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Angela Fang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sabine Wilhelm', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}