Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT00225251
Status:
COMPLETED
Last Update Posted:
2015-11-26
First Post:
2005-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Wellbutrin XL for Dysthymic Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019263', 'term': 'Dysthymic Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016642', 'term': 'Bupropion'}], 'ancestors': [{'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hellers@nyspi.columbia.edu', 'phone': '6467748000', 'title': 'David Hellerstein MD', 'organization': 'NY State Psychiatric Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Early termination led to small numbers of subjects analyzed'}}, 'adverseEventsModule': {'timeFrame': '10 weeks', 'description': 'patients were assessed for side effects over the course of the efficacy study', 'eventGroups': [{'id': 'EG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication', 'otherNumAtRisk': 11, 'otherNumAffected': 6, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day', 'otherNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'notes': 'patient reported headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dry mouth', 'notes': 'patient reported dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'notes': 'patient reported dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'insomnia', 'notes': 'reported difficulty sleeping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Depression Rating Scale, 24 Items (HDRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '13.3', 'spread': '8.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'paramValue': '3.0', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.\n\nThis study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cornell Dysthymia Rating Scale (CDRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '24', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Depression Inventory (BDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': '21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Global Improvement (CGI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '1', 'groupId': 'OG000'}, {'value': '2.43', 'spread': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': 'A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Functioning Scale (GAFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '67', 'spread': '9.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks', 'description': "A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'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': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day\n\nbupropion XL: Antidepressant medication'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '40.0', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '11.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'adults with dysthymic disorder, males and females'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-29', 'studyFirstSubmitDate': '2005-09-21', 'resultsFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2005-09-21', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-19', 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale, 24 Items (HDRS)', 'timeFrame': '10 weeks', 'description': 'Widely used depression rating scale, with higher scores reflecting greater level of depression. Assesses suicidality which is a safety issue.\n\nThis study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (\\>50% decrease) Remission (score\\<=7)'}], 'secondaryOutcomes': [{'measure': 'Cornell Dysthymia Rating Scale (CDRS)', 'timeFrame': '10 weeks', 'description': 'A 24 item scale assessing symptoms of chronic depression. Scores from 0 to 96 with higher score indicating worse depression'}, {'measure': 'Beck Depression Inventory (BDI)', 'timeFrame': '10 weeks', 'description': '21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression.'}, {'measure': 'Clinical Global Improvement (CGI)', 'timeFrame': '10 weeks', 'description': 'A global assessment of patient improvement, ranging from 1 (very much improved) to 7 (very much worse)'}, {'measure': 'Global Assessment of Functioning Scale (GAFS)', 'timeFrame': '10 weeks', 'description': "A clinician rated assessment of patient's overall functioning, ranging from 0 (severely impaired) to 100 (excellent functioning)"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysthymic Disorder', 'Dysthymia', 'Depression', 'Chronic Depression', 'Wellbutrin XL'], 'conditions': ['Dysthymic Disorder']}, 'referencesModule': {'references': [{'pmid': '11386496', 'type': 'BACKGROUND', 'citation': 'Hellerstein DJ, Batchelder S, Kreditor D, Fedak M. Bupropion sustained-release for the treatment of dysthymic disorder: an open-label study. J Clin Psychopharmacol. 2001 Jun;21(3):325-9. doi: 10.1097/00004714-200106000-00012.'}], 'seeAlsoLinks': [{'url': 'http://www.DepressionNY.com', 'label': 'For more information about our program or this study, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a ten-week, double-blind study of Wellbutrin XL in outpatients with dysthymic disorder, a form of low-grade chronic depression. We hypothesize that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.', 'detailedDescription': 'This is a ten-week, double-blind, placebo-controlled study designed to evaluate the tolerability, dosing and efficacy of Wellbutrin XL in outpatients who meet Diagnostic and Statistical Manual-IV criteria for early onset, primary type dysthymic disorder (low-grade chronic depression). It is hypothesized that patients taking Wellbutrin XL will show greater improvement in depression symptoms and psychosocial functioning than patients taking placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female outpatients 18-65 years of age.\n* Patients with a Diagnostic and Statistical Manual Fourth Edition (DSM-IV) diagnosis of dysthymic disorder, early onset.\n* Patients will have a total score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline.\n\nExclusion Criteria:\n\n* Patients with a DSM-IV diagnosis of Delirium, Dementia, and Amnestic, and other Cognitive Disorders.\n* Patients who are pregnant or nursing women.\n* Patients with a principal diagnosis meeting DSM-IV criteria for: Major Depressive disorder, Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder\n* Patients who have a current or prior diagnosis of Anorexia Nervosa or Bulimia\n* Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.\n* Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following:\n\n * Report of having a specific plan for killing themselves,\n * A score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, (indicative of active suicidal thoughts or behaviors), or\n * A suicide attempt within the past 12 months requiring emergency room visit, medical or psychiatric hospitalization, or otherwise deemed to be life-threatening (e.g. an overdose of \\> 1 week's dose of medication).\n* Patients with a history of recurrent Grand Mal seizures or at risk of Grand Mal seizures, and those with other medical conditions in which Wellbutrin XL would be contraindicated, including a history of head trauma.\n* Use of any psychotropic medication within 1 week of starting study medication\n* Use of a monoamine oxidase inhibitor (a type of antidepressant) (MAOI) within the 14 days prior to the initial dose of study medication.\n* Use of fluoxetine within 28 days of the initial dose of study medication.\n* Use of Zyban® or other forms of bupropion hydrochloride (i.e. Wellbutrin immediate release or Wellbutrin Sustained Release (SR)) within 2 weeks of the initial dose of medication.\n* Patients who have failed to respond to adequate trials (minimum of six consecutive weeks) of two different classes of antidepressant medication (see Table 1 for definitions of an adequate trial.)\n* Patients with unstable medical conditions, such as acute hyperthyroidism, uncorrected hypothyroidism, undiagnosed fever, uncontrolled angina, or any other serious medical illness, including any cardiovascular, hepatic, respiratory, hematological, endocrinologic or neurologic disease, or any clinically significant laboratory abnormality.\n* Patients who have begun a course of psychotherapy within 3 months of starting the study, or who plan to terminate an ongoing psychotherapy prior to the end of the study."}, 'identificationModule': {'nctId': 'NCT00225251', 'briefTitle': 'Wellbutrin XL for Dysthymic Disorder', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'Double-Blind Treatment of Outpatients With Dysthymic Disorder With Wellbutrin XL', 'orgStudyIdInfo': {'id': 'gsk 102149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'bupropion XL', 'description': 'Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day', 'interventionNames': ['Drug: bupropion XL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'bupropion XL', 'type': 'DRUG', 'otherNames': ['Wellbutrin XL'], 'description': 'Antidepressant medication', 'armGroupLabels': ['bupropion XL']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Mood Disorders Research Program, St. Luke's-Roosevelt Hospital Center", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David J. Hellerstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center, and NY State Psychiatric Institute"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}