Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 11:33 AM
Study NCT ID:
NCT00790868
Status:
COMPLETED
Last Update Posted:
2018-03-07
First Post:
2008-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016584', 'term': 'Panic Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003523', 'term': 'Cycloserine'}], 'ancestors': [{'id': 'D007555', 'term': 'Isoxazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D023303', 'term': 'Oxazolidinones'}, {'id': 'D010080', 'term': 'Oxazoles'}, {'id': 'D012694', 'term': 'Serine'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mwotto@bu.edu', 'phone': '(617)353-9610', 'title': 'Michael W. Otto, Ph.D.', 'organization': 'BostonUCRC'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The investigators did not systematically collect fear estimates across exposure and are therefore unable to examine this factor as a moderator.\n\nUnexpected site effects were observed for several of our outcome variables.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were monitored and elicited by open questioning of the study clinician, assessing adverse events occurring over the last hour as well as during the week following the last dose of DCS. AEs and SAEs were informally assessed up to the 6-month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 17, 'seriousNumAtRisk': 88, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 18, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Jitteriness/tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Agitation/restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness/lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety/panic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Impaired concentration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blurred vision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paresthesias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Derealization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menstrual irregularity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Pancreatitis', 'notes': 'One participant was hospitalized for pancreatitis and released the following morning. Follow-up care included additional testing to determine best course of action. This event was judged to be unrelated to the study procedures.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Appendicitis', 'notes': 'One participant was hospitalized for the treatment of appendicitis. At the time, the participant was in the active phase of the study. This event was judged to be unrelated to study procedures.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Kidney Infection', 'notes': 'A participant was hospitalized for a kidney infection for one day. This event happened prior to randomization of the study drug. The investigators judged this event to be unrelated to the study procedures.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 88, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 92, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Panic Disorder Severity Scale (PDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.30', 'spread': '4.50', 'groupId': 'OG000'}, {'value': '13.37', 'spread': '3.39', 'groupId': 'OG001'}]}]}, {'title': 'TX Midpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.98', 'spread': '3.92', 'groupId': 'OG000'}, {'value': '8.32', 'spread': '4.19', 'groupId': 'OG001'}]}]}, {'title': 'TX Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '3.52', 'groupId': 'OG000'}, {'value': '6.43', 'spread': '4.63', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.76', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '5.84', 'spread': '4.36', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.38', 'spread': '3.50', 'groupId': 'OG000'}, {'value': '4.53', 'spread': '4.03', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.46', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '4.35', 'spread': '4.07', 'groupId': 'OG001'}]}]}, {'title': 'Follow-Up 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.85', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '3.45', 'spread': '3.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-TX, post-TX, follow-up visits 1-4', 'description': 'The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Seventeen subjects out of 92 (five during treatment and 12 during follow-up, 20% total) in the control group compared to six out of 88 (four during treatment and two during follow-up, 10% total) in the DCS group dropped out.'}, {'type': 'PRIMARY', 'title': 'Remission Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nd-cycloserine: 50mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'placebo-augmented CBT\n\nplacebo: 50mg'}], 'classes': [{'title': 'Mid-Treatment', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Tx Endpoint', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-2', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-3', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-4', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-treatment, Post-Treatment, and each follow-up sessions', 'description': 'Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the "CGI-S of 1 or 2" component of the "remission status" criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full sample of 180 randomized participants'}, {'type': 'SECONDARY', 'title': 'Depression Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '8.5', 'groupId': 'OG000'}, {'value': '11.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}, {'title': 'Treatment Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.9', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '7.8', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '8.4', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants with panic disorder'}, {'type': 'SECONDARY', 'title': 'Quality of Life Ratings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.2', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'TX - Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '52.7', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.9', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '52.2', 'spread': '9.4', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.3', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '53.4', 'spread': '9.2', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.6', 'spread': '8.4', 'groupId': 'OG000'}, {'value': '55.1', 'spread': '8.6', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '54.7', 'spread': '8.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized participants'}, {'type': 'SECONDARY', 'title': 'Role Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'TX - Endpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '7.9', 'spread': '2.7', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized sample'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '98 participants were deemed ineligible at baseline and 15 others were not randomized.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '88'}, {'groupId': 'FG001', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'comment': 'All randomized participants (n = 180) were included in data analysis.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Participants were recruited and enrolled at Boston University (n = 68), the Institute of Living in Hartford, Connecticut (n = 59), and a combined site of Massachusetts General Hospital and Rush University Medical Center (n = 53). Results presented here are for all sites.', 'preAssignmentDetails': '293 individuals completed baseline evaluations. Of these, 98 were deemed ineligible (e.g., other primary diagnosis, medication exclusion) at the initial screening visit. An additional 15 participants were not randomized due to withdrawal (n = 4), lost to follow-up (n = 10), and changes to medication (n = 1). 180 participants were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'D-cycloserine', 'description': 'DCS-augmented CBT\n\nD-cycloserine: 50mg'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo-augmented CBT\n\nPlacebo: 50mg'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '175', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants.'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '35.75', 'spread': '11.59', 'groupId': 'BG000'}, {'value': '35.18', 'spread': '12.84', 'groupId': 'BG001'}, {'value': '35.4', 'spread': '12.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Measure Analysis Population Description: Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants (with 1 subject missing ethnicity, and 1 subject missing race due to confused reporting of these terms).'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', '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': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants (with 1 subject missing ethnicity, and 1 subject missing race due to confused reporting of these terms).'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Boston University', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': 'Institute of Living in Hartford, Connecticut', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'Massachusetts General Hospital/Rush', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Complete demographic information was collected for 178 participants. Some or all demographic information is missing for the remaining 2 participants.'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-05', 'studyFirstSubmitDate': '2008-11-13', 'resultsFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-05', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Panic Disorder Severity Scale (PDSS)', 'timeFrame': 'baseline, mid-TX, post-TX, follow-up visits 1-4', 'description': 'The percent change in PDSS score from baseline to the relevant assessment points is the continuous primary outcome measure. The PDSS consists of seven items, each rated on a 0 to 4 scale (0 denoting none, and higher ratings reflecting greater degrees of symptom severity; for a possible range in scores from 0 to 28). In the tabular data below we present the total scores (sum of items).'}, {'measure': 'Remission Status', 'timeFrame': 'Pre-treatment, Post-Treatment, and each follow-up sessions', 'description': 'Remission status will be used as the primary categorical outcome variable. The CGI-S was used in determining whether patients met the "CGI-S of 1 or 2" component of the "remission status" criteria (i.e., zero panic attacks and CGI-S of 1 or 2 at endpoint). No values are missing because remission must be confirmed; missing status is assigned to disorder status. Hence results are for the full randomized sample.'}], 'secondaryOutcomes': [{'measure': 'Depression Severity', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'Depression severity was assessed with the MADRS, with scores ranging from 0 to 60. Higher scores indicate greater depression.'}, {'measure': 'Quality of Life Ratings', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'Quality of life as assessed by the Q-LES-Q. Scores range from 14-70 for total raw score, higher scores indicate higher quality of life ratings.'}, {'measure': 'Role Functioning', 'timeFrame': 'Baseline, Tx Endpoint, Each of 4 follow-up assessments', 'description': 'LIFE-RIFT. For this clinician-rated measure, total scores range from 0 to 20, with higher scores indicating greater impairment'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Panic Disorder', 'Anxiety', 'D-cycloserine', 'DCS', 'Cognitive Behavioral Therapy', 'CBT'], 'conditions': ['Panic Disorder']}, 'referencesModule': {'references': [{'pmid': '27315514', 'type': 'RESULT', 'citation': 'Otto MW, Pollack MH, Dowd SM, Hofmann SG, Pearlson G, Szuhany KL, Gueorguieva R, Krystal JH, Simon NM, Tolin DF. RANDOMIZED TRIAL OF D-CYCLOSERINE ENHANCEMENT OF COGNITIVE-BEHAVIORAL THERAPY FOR PANIC DISORDER. Depress Anxiety. 2016 Aug;33(8):737-45. doi: 10.1002/da.22531. Epub 2016 Jun 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a 5-year double blind, randomized, controlled, trial conducted at three treatment sites, aimed at showing the acute and longer-term effects of DCS augmentation of exposure-based CBT for panic disorder relative to placebo augmentation. By demonstrating that DCS can enhance the results of even a brief treatment strategy, the investigators are seeking to validate an approach that fits well with the practice limitations and applications of CBT in effectiveness studies.', 'detailedDescription': 'In this application, the investigators propose to further validate and expand upon one of the apparent striking successes of translational research. Specifically, basic research on the neural circuitry underlying fear extinction led to the examination of d-cycloserine (DCS), a partial agonist of the NMDA receptor in the amygdala, as an agent capable of enhancing extinction learning (Davis et al., 2006; Davis et al., in press). Following successful validation of this strategy in the animal laboratory (see Ledgerwood et al., 2005; Richardson et al., 2004), Ressler et al. (2004) showed that single doses of d-cycloserine (DCS) could enhance extinction in a human exposure paradigm for height phobic adults. This exciting initial finding was replicated by this research team for the treatment of social anxiety disorder (Hofmann et al., 2006), as well as an initial pilot study of the treatment of panic disorder (Tolin et al., 2006). As discussed by Anderson and Insel (2006), these findings have the potential to foster significant advances in the treatment of anxiety disorders. The present study represents the further application of DCS for augmenting the effects of exposure-based cognitive-behavior therapy (CBT), now applied to the treatment of panic disorder with or without agoraphobia.\n\nIn the current application, the investigators propose a five-year study to show the acute and longer-term effects of DCS augmentation of exposure-based CBT relative to placebo augmentation. This study is noteworthy for the use of a brief treatment strategy that has been shown to be successful in previous trials (e.g., Clark et al., 1999; Roy-Byrne et al., 2005) and has served as the basis for the DCS augmentation effect seen in a pilot study for this application. By demonstrating that DCS can enhance the results of even a brief treatment strategy, the investigators are seeking to validate an approach that fits well with the practice limitations and applications of CBT in effectiveness studies (e.g., Katon et al., 2006; Roy-Byrne et al. 2005). Furthermore, by studying the genetic predictors of the overall response to CBT, and DCS augmentation in particular, the investigators hope to further elucidate the nature of DCS augmentation and the selection of particularly responsive subgroups of patients in need. This agenda is in accords with "the ultimate goal of personalized therapy: identifying individual patterns of pathophysiology that indicate which pharmacological or behavioral treatment will be most useful for any individual patient" (Anderson \\& Insel, 2006, p. 320).\n\nThe study design is a double blind, randomized, controlled, trial conducted at three treatment sites. Patient with panic disorder will randomly receive DCS or placebo 1 hour prior to sessions 3-5 of a 5-session CBT protocol that includes 2 additional booster sessions over the course of follow-up. Patients will be enrolled over 5 years with the identical treatment protocol followed at each of the sites. Sites will nonetheless differ with respect to study management and analysis procedures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients \\> 18 years of age with a primary psychiatric diagnosis of panic disorder with or without agoraphobia\n* CGI-severity score of 4 or higher\n* Physical examination and laboratory findings without clinically significant abnormalities\n* Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose\n* Willingness and ability to comply with the requirements of the study protocol\n\nExclusion Criteria:\n\n* Agoraphobia sufficiently severe as to limit patient's ability to travel to and participate in weekly sessions Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months\n* Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder\n* Significant suicidal ideation or suicidal behaviors within the past 6 months\n* Significant personality dysfunction likely to interfere with study participation\n* Serious medical illness or instability for which hospitalization may be likely within the next year\n* Patients with a current or past history of seizures (other than febrile seizures in childhood)\n* Pregnant women, lactating women, and women of childbearing potential who are not using medically accepted forms of contraception\n* Concurrent psychotherapy initiated within 3 months of baseline, or ongoing psychotherapy of any duration directed specifically toward treatment of the panic disorder other than general supportive therapy initiated at least 3 months prior to study\n* Prior adequate trial of CBT for panic disorder"}, 'identificationModule': {'nctId': 'NCT00790868', 'acronym': 'DCSPanic', 'briefTitle': 'Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Boston University Charles River Campus'}, 'officialTitle': 'Exposure, D-Cycloserine Enhancement, and Genetic Modulators in Panic Disorder', 'orgStudyIdInfo': {'id': 'R01MH081116', 'link': 'https://reporter.nih.gov/quickSearch/R01MH081116', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R01MH081116', 'link': 'https://reporter.nih.gov/quickSearch/R01MH081116', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-cycloserine', 'description': 'DCS-augmented CBT', 'interventionNames': ['Drug: d-cycloserine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo-augmented CBT', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'd-cycloserine', 'type': 'DRUG', 'otherNames': ['DCS'], 'description': '50mg', 'armGroupLabels': ['D-cycloserine']}, {'name': 'placebo', 'type': 'DRUG', 'description': '50mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06106', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Institute of Living', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Michael W Otto, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Boston University'}, {'name': 'David F Tolin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Living'}, {'name': 'Mark H Pollack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston University Charles River Campus', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ph.D.', 'investigatorFullName': 'Michael Otto', 'investigatorAffiliation': 'Boston University Charles River Campus'}}}}