Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:49 PM
Study NCT ID:
NCT01407094
Status:
COMPLETED
Last Update Posted:
2018-12-26
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D019964', 'term': 'Mood Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'madhukar.trivedi@UTSouthwestern.edu', 'phone': '214-648-0188', 'title': 'Dr. Madhukar H. Trivedi', 'organization': 'University of Texas Southwestern Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks for each Stage (1 and 2)', 'description': 'For both Serious and Other adverse events: SERT total is the sum of Stages 1 or 2, Treatment A plus Treatment D (210+73); PBO total is the sum of Stages 1 or 2, Treatment B (150+46). BUP was only used during Stage 2 (Treatment C).', 'eventGroups': [{'id': 'EG000', 'title': 'Sertraline', 'description': 'SSRI monotherapy\n\nSertraline: 50-200mg/day', 'otherNumAtRisk': 283, 'otherNumAffected': 233, 'seriousNumAtRisk': 283, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo control\n\nPlacebo: 1-4 pills per day', 'otherNumAtRisk': 196, 'otherNumAffected': 89, 'seriousNumAtRisk': 196, 'seriousNumAffected': 7}, {'id': 'EG002', 'title': 'BupropionXL', 'description': 'BupropionXL\n\n150-450 mg/day', 'otherNumAtRisk': 53, 'otherNumAffected': 27, 'seriousNumAtRisk': 53, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 46, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 57, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'ER Visit', 'notes': 'Type-I Diabetes with brittle blood sugar control; hospital admin w/ ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER Visit', 'notes': 'ER visit with diagnosis of acute cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER Visit', 'notes': 'ER visit with fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'notes': 'Emergent suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER Visit', 'notes': 'Chest pain with emergency hospitalization; diagnosis of non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'notes': 'Involuntary hospitalization for suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'notes': 'Worsening depression, suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'notes': 'Panic attack, arrested', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Panic attack', 'notes': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'notes': 'Became pregnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER Visit', 'notes': 'Chest pain with emergency hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ER Visit', 'notes': 'Worsening depression, suicidal ideation to ER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidality', 'notes': 'Hospitalization for suicidality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pregnancy', 'notes': 'Exited study due to pregnancy on 9/16/12 and gave birth to microcephalic child on 5/7/13', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'notes': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'Worsening depression, suicidal ideation; psych hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 283, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 196, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 53, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Rating Scale for Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Sertraline', 'description': 'SSRI monotherapy\n\nSertraline: 50-200mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo control\n\nPlacebo: 1-4 pills per day'}, {'id': 'OG002', 'title': 'BupropionXL', 'description': 'BupropionXL\n\n150-450mg/day'}], 'classes': [{'categories': [{'measurements': [{'value': '11.06', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '12.52', 'spread': '7.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 8', 'description': 'The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)\n\n* Scores range from 0-52\n* Lower scores indicate less depressive symptomatology, and so are the more desirable.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Note subjects in the efficacy trial were those that completed 8 weeks of treatment, 115 in the sertraline group, and 123 in the placebo group. SERT had 34 wash-outs, PBO had 27.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sertraline', 'description': 'SSRI monotherapy\n\nSertraline: 50-200mg/day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo control\n\nPlacebo: 1-4 pills per day'}, {'id': 'FG002', 'title': 'BupropionXL', 'description': 'BupropionXL\n\n150-450 mg/day\n\nOther names: WelbutrinXL'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Stage 1 Sertraline (SERT): 34 exited', 'groupId': 'FG000', 'numSubjects': '146'}, {'comment': 'Stage 1 Placebo (PBO): 27 exited.', 'groupId': 'FG001', 'numSubjects': '150'}, {'comment': 'Bupropion (BUP) was used only in Stage 2 for non-responders to SERT.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'One participant completed Stage 1 but did not continue to Stage 2.', 'groupId': 'FG000', 'numSubjects': '112'}, {'comment': 'Four participants completed Stage 1 but did not continue to Stage 2.', 'groupId': 'FG001', 'numSubjects': '123'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Stage 2 SERT includes Stage 1 SERT responders (n=61) and Stage 1 PBO non-responders (n=73).', 'groupId': 'FG000', 'numSubjects': '134'}, {'comment': 'Stage 2 PBO includes Stage 1 PBO responders (n=47); 1 early exit (n=46).', 'groupId': 'FG001', 'numSubjects': '46'}, {'comment': 'Stage 2 BUP includes Stage 1 SERT non-responders (n=54); 1 early exit (n=53).', 'groupId': 'FG002', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '113'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}]}]}], 'preAssignmentDetails': 'Final enrollment Stage 1: 296 (146 SERT, 150 PBO). Individuals who responded to their Stage 1 treatment remained on that treatment in Stage 2. Individuals who did not respond to their Stage 1 treatment were switched to a different treatment in Stage 2.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '296', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sertraline', 'description': 'SSRI monotherapy\n\nSertraline: 50-200mg/day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo control\n\nPlacebo: 1-4 pills per day'}, {'id': 'BG002', 'title': 'BupropionXL', 'description': 'BupropionXL\n\n150-450mg/day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '145', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Of the 299 participants who were randomized, 3 were randomized but did not meet criteria, resulting in 296 who were randomized and assessed.'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '36.9', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '37.05', 'spread': '13.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Measure Analysis Population Description: Of the 299 participants who were randomized, 3 were randomized but did not meet criteria, resulting in 296 who were randomized and assessed'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '146', 'groupId': 'BG000'}, {'value': '150', 'groupId': 'BG001'}, {'value': '296', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': "Stage 1 is made up of Treatment A (SERT) and Treatment B (PBO). Non-responders to Treatment A were switched in Stage 2 to BUP, and non-responders in Treatment B were switched to SERT. Between randomization and baseline, 3 participants didn't meet inclusion criteria, hence the discrepancy between official enrollment and baseline population numbers."}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Patients were entered into Stage 1, treated with sertraline (Treatment A) or placebo (Treatment B), and used for the primary analysis which included the identification of potential mediators and moderators of response for these two treatments.\n\nIn stage two, responders to Treatment A remained on sertraline, and non-responders were switched to bupropion (Treatment C). Responders to Treatment B remained on placebo, and non-responders were switched to sertraline (Treatment D).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 296}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-03', 'studyFirstSubmitDate': '2011-07-25', 'resultsFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2011-07-29', 'lastUpdatePostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-03', 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression', 'timeFrame': 'Week 8', 'description': 'The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)\n\n* Scores range from 0-52\n* Lower scores indicate less depressive symptomatology, and so are the more desirable.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Depression, Major Depressive Disorder, Mood Disorder'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '25961712', 'type': 'BACKGROUND', 'citation': 'Chase HW, Fournier JC, Greenberg T, Almeida JR, Stiffler R, Zevallos CR, Aslam H, Cooper C, Deckersbach T, Weyandt S, Adams P, Toups M, Carmody T, Oquendo MA, Peltier S, Fava M, McGrath PJ, Weissman M, Parsey R, McInnis MG, Kurian B, Trivedi MH, Phillips ML. Accounting for Dynamic Fluctuations across Time when Examining fMRI Test-Retest Reliability: Analysis of a Reward Paradigm in the EMBARC Study. PLoS One. 2015 May 11;10(5):e0126326. doi: 10.1371/journal.pone.0126326. eCollection 2015.'}, {'pmid': '28983519', 'type': 'BACKGROUND', 'citation': 'Fournier JC, Chase HW, Greenberg T, Etkin A, Almeida JR, Stiffler R, Deckersbach T, Weyandt S, Cooper C, Toups M, Carmody T, Kurian B, Peltier S, Adams P, McInnis MG, Oquendo MA, McGrath PJ, Fava M, Weissman M, Parsey R, Trivedi MH, Phillips ML. Neuroticism and Individual Differences in Neural Function in Unmedicated Major Depression: Findings from the EMBARC Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2017 Mar;2(2):138-148. doi: 10.1016/j.bpsc.2016.11.008. Epub 2016 Dec 6.'}, {'pmid': '26183698', 'type': 'BACKGROUND', 'citation': 'Greenberg T, Chase HW, Almeida JR, Stiffler R, Zevallos CR, Aslam HA, Deckersbach T, Weyandt S, Cooper C, Toups M, Carmody T, Kurian B, Peltier S, Adams P, McInnis MG, Oquendo MA, McGrath PJ, Fava M, Weissman M, Parsey R, Trivedi MH, Phillips ML. Moderation of the Relationship Between Reward Expectancy and Prediction Error-Related Ventral Striatal Reactivity by Anhedonia in Unmedicated Major Depressive Disorder: Findings From the EMBARC Study. Am J Psychiatry. 2015 Sep 1;172(9):881-91. doi: 10.1176/appi.ajp.2015.14050594. Epub 2015 Jul 17.'}, {'pmid': '28670629', 'type': 'BACKGROUND', 'citation': 'Petkova E, Ogden RT, Tarpey T, Ciarleglio A, Jiang B, Su Z, Carmody T, Adams P, Kraemer HC, Grannemann BD, Oquendo MA, Parsey R, Weissman M, McGrath PJ, Fava M, Trivedi MH. Statistical Analysis Plan for Stage 1 EMBARC (Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care) Study. Contemp Clin Trials Commun. 2017 Jun;6:22-30. doi: 10.1016/j.conctc.2017.02.007. Epub 2017 Feb 24.'}, {'pmid': '29641834', 'type': 'BACKGROUND', 'citation': 'Pizzagalli DA, Webb CA, Dillon DG, Tenke CE, Kayser J, Goer F, Fava M, McGrath P, Weissman M, Parsey R, Adams P, Trombello J, Cooper C, Deldin P, Oquendo MA, McInnis MG, Carmody T, Bruder G, Trivedi MH. Pretreatment Rostral Anterior Cingulate Cortex Theta Activity in Relation to Symptom Improvement in Depression: A Randomized Clinical Trial. JAMA Psychiatry. 2018 Jun 1;75(6):547-554. doi: 10.1001/jamapsychiatry.2018.0252.'}, {'pmid': '30110685', 'type': 'BACKGROUND', 'citation': 'Trivedi MH, South C, Jha MK, Rush AJ, Cao J, Kurian B, Phillips M, Pizzagalli DA, Trombello JM, Oquendo MA, Cooper C, Dillon DG, Webb C, Grannemann BD, Bruder G, McGrath PJ, Parsey R, Weissman M, Fava M. A Novel Strategy to Identify Placebo Responders: Prediction Index of Clinical and Biological Markers in the EMBARC Trial. Psychother Psychosom. 2018;87(5):285-295. doi: 10.1159/000491093. Epub 2018 Aug 15.'}, {'pmid': '27038550', 'type': 'BACKGROUND', 'citation': 'Trivedi MH, McGrath PJ, Fava M, Parsey RV, Kurian BT, Phillips ML, Oquendo MA, Bruder G, Pizzagalli D, Toups M, Cooper C, Adams P, Weyandt S, Morris DW, Grannemann BD, Ogden RT, Buckner R, McInnis M, Kraemer HC, Petkova E, Carmody TJ, Weissman MM. Establishing moderators and biosignatures of antidepressant response in clinical care (EMBARC): Rationale and design. J Psychiatr Res. 2016 Jul;78:11-23. doi: 10.1016/j.jpsychires.2016.03.001. Epub 2016 Mar 15.'}, {'pmid': '29689518', 'type': 'BACKGROUND', 'citation': 'Trombello JM, Pizzagalli DA, Weissman MM, Grannemann BD, Cooper CM, Greer TL, Malchow AL, Jha MK, Carmody TJ, Kurian BT, Webb CA, Dillon DG, McGrath PJ, Bruder G, Fava M, Parsey RV, McInnis MG, Adams P, Trivedi MH. Characterizing anxiety subtypes and the relationship to behavioral phenotyping in major depression: Results from the EMBARC study. J Psychiatr Res. 2018 Jul;102:207-215. doi: 10.1016/j.jpsychires.2018.04.003. Epub 2018 Apr 6.'}, {'pmid': '30182751', 'type': 'BACKGROUND', 'citation': 'Ulke C, Tenke CE, Kayser J, Sander C, Bottger D, Wong LYX, Alvarenga JE, Fava M, McGrath PJ, Deldin PJ, Mcinnis MG, Trivedi MH, Weissman MM, Pizzagalli DA, Hegerl U, Bruder GE. Resting EEG Measures of Brain Arousal in a Multisite Study of Major Depression. Clin EEG Neurosci. 2019 Jan;50(1):3-12. doi: 10.1177/1550059418795578. Epub 2018 Sep 5.'}, {'pmid': '29962359', 'type': 'BACKGROUND', 'citation': 'Webb CA, Trivedi MH, Cohen ZD, Dillon DG, Fournier JC, Goer F, Fava M, McGrath PJ, Weissman M, Parsey R, Adams P, Trombello JM, Cooper C, Deldin P, Oquendo MA, McInnis MG, Huys Q, Bruder G, Kurian BT, Jha M, DeRubeis RJ, Pizzagalli DA. Personalized prediction of antidepressant v. placebo response: evidence from the EMBARC study. Psychol Med. 2019 May;49(7):1118-1127. doi: 10.1017/S0033291718001708. Epub 2018 Jul 2.'}, {'pmid': '36586213', 'type': 'DERIVED', 'citation': 'Chin Fatt CR, Minhajuddin A, Jha MK, Mayes T, Rush AJ, Trivedi MH. Data driven clusters derived from resting state functional connectivity: Findings from the EMBARC study. J Psychiatr Res. 2023 Feb;158:150-156. doi: 10.1016/j.jpsychires.2022.12.002. Epub 2022 Dec 27.'}, {'pmid': '34000130', 'type': 'DERIVED', 'citation': 'Jha MK, Schatzberg A, Minhajuddin A, Chin Fatt C, Mayes TL, Trivedi MH. Cross-Sectional Associations Among Symptoms of Pain, Irritability, and Depression and How These Symptoms Relate to Social Functioning and Quality of Life: Findings From the EMBARC and STRIDE Studies and the VitalSign6 Project. J Clin Psychiatry. 2021 Apr 13;82(3):20m13740. doi: 10.4088/JCP.20m13740.'}, {'pmid': '33038902', 'type': 'DERIVED', 'citation': 'Jha MK, Fava M, Minhajuddin A, Chin Fatt C, Mischoulon D, Cusin C, Trivedi MH. Association of anger attacks with suicidal ideation in adults with major depressive disorder: Findings from the EMBARC study. Depress Anxiety. 2021 Jan;38(1):57-66. doi: 10.1002/da.23095. Epub 2020 Oct 10.'}, {'pmid': '32921587', 'type': 'DERIVED', 'citation': 'Chin Fatt CR, Cooper C, Jha MK, Aslan S, Grannemann B, Kurian B, Greer TL, Fava M, Weissman M, McGrath PJ, Parsey RV, Etkin A, Phillips ML, Trivedi MH. Dorsolateral Prefrontal Cortex and Subcallosal Cingulate Connectivity Show Preferential Antidepressant Response in Major Depressive Disorder. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Jan;6(1):20-28. doi: 10.1016/j.bpsc.2020.06.019. Epub 2020 Jul 8.'}, {'pmid': '32658822', 'type': 'DERIVED', 'citation': 'Jha MK, Minhajuddin A, Chin Fatt C, Trivedi MH. Improvements in irritability with sertraline versus placebo: Findings from the EMBARC study. J Affect Disord. 2020 Oct 1;275:44-47. doi: 10.1016/j.jad.2020.06.021. Epub 2020 Jun 26.'}, {'pmid': '31895437', 'type': 'DERIVED', 'citation': 'Rolle CE, Fonzo GA, Wu W, Toll R, Jha MK, Cooper C, Chin-Fatt C, Pizzagalli DA, Trombello JM, Deckersbach T, Fava M, Weissman MM, Trivedi MH, Etkin A. Cortical Connectivity Moderators of Antidepressant vs Placebo Treatment Response in Major Depressive Disorder: Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2020 Apr 1;77(4):397-408. doi: 10.1001/jamapsychiatry.2019.3867.'}, {'pmid': '31537090', 'type': 'DERIVED', 'citation': 'Chin Fatt CR, Jha MK, Cooper CM, Fonzo G, South C, Grannemann B, Carmody T, Greer TL, Kurian B, Fava M, McGrath PJ, Adams P, McInnis M, Parsey RV, Weissman M, Phillips ML, Etkin A, Trivedi MH. Effect of Intrinsic Patterns of Functional Brain Connectivity in Moderating Antidepressant Treatment Response in Major Depression. Am J Psychiatry. 2020 Feb 1;177(2):143-154. doi: 10.1176/appi.ajp.2019.18070870. Epub 2019 Sep 20.'}, {'pmid': '31193824', 'type': 'DERIVED', 'citation': 'Cooper CM, Chin Fatt CR, Jha M, Fonzo GA, Grannemann BD, Carmody T, Ali A, Aslan S, Almeida JRC, Deckersbach T, Fava M, Kurian BT, McGrath PJ, McInnis M, Parsey RV, Weissman M, Phillips ML, Lu H, Etkin A, Trivedi MH. Cerebral Blood Perfusion Predicts Response to Sertraline versus Placebo for Major Depressive Disorder in the EMBARC Trial. EClinicalMedicine. 2019 May 18;10:32-41. doi: 10.1016/j.eclinm.2019.04.007. eCollection 2019 Apr.'}, {'pmid': '31158720', 'type': 'DERIVED', 'citation': 'Pillai RLI, Huang C, LaBella A, Zhang M, Yang J, Trivedi M, Weissman M, McGrath P, Fava M, Kurian B, Cooper C, McInnis M, Oquendo MA, Pizzagalli DA, Parsey RV, DeLorenzo C. Examining raphe-amygdala structural connectivity as a biological predictor of SSRI response. J Affect Disord. 2019 Sep 1;256:8-16. doi: 10.1016/j.jad.2019.05.055. Epub 2019 May 28.'}, {'pmid': '30718038', 'type': 'DERIVED', 'citation': 'Whitton AE, Webb CA, Dillon DG, Kayser J, Rutherford A, Goer F, Fava M, McGrath P, Weissman M, Parsey R, Adams P, Trombello JM, Cooper C, Deldin P, Oquendo MA, McInnis MG, Carmody T, Bruder G, Trivedi MH, Pizzagalli DA. Pretreatment Rostral Anterior Cingulate Cortex Connectivity With Salience Network Predicts Depression Recovery: Findings From the EMBARC Randomized Clinical Trial. Biol Psychiatry. 2019 May 15;85(10):872-880. doi: 10.1016/j.biopsych.2018.12.007. Epub 2018 Dec 19.'}, {'pmid': '30699849', 'type': 'DERIVED', 'citation': 'Liao A, Walker R, Carmody TJ, Cooper C, Shaw MA, Grannemann BD, Adams P, Bruder GE, McInnis MG, Webb CA, Dillon DG, Pizzagalli DA, Phillips ML, Kurian BT, Fava M, Parsey RV, McGrath PJ, Weissman MM, Trivedi MH. Anxiety and anhedonia in depression: Associations with neuroticism and cognitive control. J Affect Disord. 2019 Feb 15;245:1070-1078. doi: 10.1016/j.jad.2018.11.072. Epub 2018 Nov 14.'}]}, 'descriptionModule': {'briefSummary': 'This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a biosignature of treatment response for depression. Evaluation of the usefulness of these markers in a carefully conducted clinical trial comparing an antidepressant to placebo will assist in developing a Depression Treatment Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely selection of treatments best suited for individual patients and thus approaching personalized treatment. The resulting index provides a truly novel means of synthesizing the contribution of key clinical and biological parameters in an easy to use tool for clinical care.', 'detailedDescription': 'The current study is designed to identify biomarkers for the prediction of differential treatment outcomes between the SSRI antidepressant sertraline (SERT) and placebo (PBO) in a randomized trial for patients with MDD. In addition, a second stage will collect data to explore moderators and mediators of treatment outcomes between pharmacologically distinct active treatment arms: sertraline (SERT), a serotonergic antidepressant or bupropion (BUP), a nonserotonergic antidepressant. To reduce biologic heterogeneity, we will only enroll patients with early onset of DSM IV MDD (before age 30) because these criteria in probands have been shown to be associated with increased familial loading in families. Patients will also have recurrent MDD with 2 or more recurrences (including current episode). Additionally, patients will be required to have a current symptom severity score of 14 or more on the Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR), both at study screening and at the randomization (baseline) visit. In the first stage, patients will receive an 8-week course of treatment in one of the two study arms. As part of the Sequential Multiple Assignment Randomized Trial (SMART) design patients that have not achieved a response at the end of 8 weeks to their stage one treatment, defined by \\< 50% improvement on the Clinical Global Improvement scale (CGI), will be switched to Stage 2 treatment (8 weeks). Patients who have achieved satisfactory response (\\>= 50% improvement on the CGI) will be continued on treatment for an additional 8 weeks.\n\nSpecific Aims\n\nModerator Aims (Aim 1): To identify baseline clinical, neuroimaging, neurophysiological, and behavioral moderators of differential treatment outcome (mean symptom change and tolerability) for sertraline (SERT, a serotonergic antidepressant) versus placebo (PBO) for the treatment of MDD. Symptom change will be measured using the mean change from baseline in the 17-item Hamilton Rating Scale for Depression (HRSD17). Tolerability will be measured using the Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) and the Treatment Emergent Symptom Scale (TESS).\n\nMediator Aims (Aim 2): To identify early phase (week 1) changes in neuroimaging, neurophysiological, and behavioral tasks as mediators of differential treatment outcomes (symptom change, tolerability) to SERT and PBO.\n\nMain Treatment Effects Aim (Aim 3): To compare the 8-week outcomes of SERT vs. PBO using mixed model regression analysis to maximize power to discriminate treatment efficacy differences.\n\nPrimary Outcomes:\n\n\\- 17-item Hamilton Rating Scale for Depression (HRSD17)\n\nSecondary Outcomes:\n\n\\- the Frequency, Intensity, and Burden Side Effects Rating (FIBSER)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults, age 18-65\n* Written informed consent obtained\n* Outpatients with a current primary diagnosis of nonpsychotic recurrent or chronic MDD per the SCID-I\n* QIDS-SR score of ≥ 14 at Screening Visit and Randomization (Baseline) Visit\n* No failed antidepressant trials of adequate dose and duration, as defined by the MGH-ATRQ, in the current episode\n* Agrees to, and is eligible for, all biomarkers procedures (EEG/psychological testing, MRI, and blood draws)\n\nExclusion Criteria:\n\n* History of inadequate response (to trials at adequate dose for adequate duration) or poor tolerability to sertraline (SERT) or bupropion (BUP)\n* Pregnant or breastfeeding\n* Plan to become pregnant over the ensuing 12 months following study entry or are sexually active and not using adequate contraception\n* History (lifetime) of psychotic depression, schizophrenia, bipolar (I, II, or NOS) disorder, schizoaffective disorder, or other Axis I psychotic disorder\n* Current primary anxiety disorder diagnosis\n* Meeting DSM-IV criteria for substance abuse in the last 2 months or substance dependence in the last 6 months (except for nicotine)\n* Require immediate hospitalization for psychiatric disorder\n* Have an unstable general medical condition (GMC) that will likely require hospitalization or to be deemed terminal (life expectancy \\< 6 months after study entry)\n* Require medications for their GMCs that contraindicate any study medication\n* Have epilepsy or other conditions requiring an anticonvulsant\n* Receiving or have received during the index episode vagus nerve stimulation, ECT, or rTMS, or other somatic antidepressant treatments\n* Currently taking any of the following exclusionary medications: antipsychotic medications, anticonvulsant medications, mood stabilizers, central nervous system stimulants, daily use of benzodiazepines or hypnotics, or antidepressant medication used for the treatment of depression or other purposes such as smoking cessation, since these agents may interfere with the testing of the major hypotheses under study. Nonexcluded concomitant medications are acceptable as long as their clinician determines that antidepressant treatment is safe and appropriate.\n* Significant liver disease that would contraindicate any study medication\n* Taking thyroid medication for hypothyroidism may be included only if they have been stable on the thyroid medication for 3 months\n* Using agents that are potential augmenting agents (e.g., T3 in the absence of thyroid disease, SAMe, St. John's Wort, lithium, buspirone, Omega 3 fatty acids)\n* Therapy that is depression specific, such as CBT or Interpersonal Psychotherapy of Depression (IPT) is not allowed during participation (participants can participate if they are receiving psychotherapy that is not targeting the symptoms of depression, such as supportive therapy, marital therapy).\n* Subjects must be fluent in English and have the capacity to understand the nature of the study and sign the written informed consent since non-English speaking personnel are not available for this study, and the research instruments are not yet translated and validated in other languages.\n* Currently actively suicidal or considered a high suicide risk\n* Are currently enrolled in another study, and participation in that study contraindicates participation in the EMBARC study.\n* Any reason not listed herein yet, determined by the site PI, medical personnel, or designee that constitutes good clinical practice and that would in the opinion of the site PI, medical personnel, or designee make participation in the study hazardous."}, 'identificationModule': {'nctId': 'NCT01407094', 'acronym': 'EMBARC', 'briefTitle': 'Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) for Depression', 'orgStudyIdInfo': {'id': 'STU 092010-151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sertraline', 'description': 'SSRI monotherapy', 'interventionNames': ['Drug: Sertraline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo control', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupropion', 'description': 'BupropionXL', 'interventionNames': ['Drug: BupropionXL']}], 'interventions': [{'name': 'Sertraline', 'type': 'DRUG', 'otherNames': ['Zoloft'], 'description': '50-200mg/day', 'armGroupLabels': ['Sertraline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1-4 pills per day', 'armGroupLabels': ['Placebo']}, {'name': 'BupropionXL', 'type': 'DRUG', 'otherNames': ['WelbutrinXL'], 'description': '150-450 mg/day', 'armGroupLabels': ['Bupropion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Ann Arbor', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia Univerisity New York City', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75309', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Madhukar H Trivedi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}, {'name': 'Patrick J McGrath, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Myrna Weissman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Ramin Parsey, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Maurizio Fava, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Madhukar H. Trivedi', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}