Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2026-01-01 @ 5:24 PM
Study NCT ID:
NCT01537068
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2012-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Desvenlafaxine vs. Placebo Treatment of Chronic Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019263', 'term': 'Dysthymic Disorder'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069468', 'term': 'Desvenlafaxine Succinate'}], 'ancestors': [{'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'desdesk@nyspi.columbia.edu', 'phone': '646-774-8000', 'title': 'David Hellerstein MD', 'organization': 'NYSPI'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Desvenlafaxine', 'description': 'SNRI antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day', 'otherNumAtRisk': 30, 'otherNumAffected': 29, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills', 'otherNumAtRisk': 29, 'otherNumAffected': 19, 'seriousNumAtRisk': 29, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Decreased sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Daytime Sleepiness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Sweating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Seizure', 'notes': 'Patient was treated with placebo and this was an pre-existing condition.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Hamilton Rating Scale for Depression (HDRS24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desvenlafaxine', 'description': 'SNRI antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills'}], 'classes': [{'categories': [{'measurements': [{'value': '14.63', 'spread': '3.39', 'groupId': 'OG000'}, {'value': '14.21', 'spread': '3.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.09', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Test of Within-subjects effects', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Repeated Measures of ANOVA'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hamilton Rating Scale for Depression (HDRS24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desvenlafaxine', 'description': 'SNRI antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills'}], 'classes': [{'categories': [{'measurements': [{'value': '6.53', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '4.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Desvenlafaxine', 'description': 'SNRI antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Chi-squared', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.32', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Desvenlafaxine', 'description': 'Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Desvenlafaxine', 'description': 'SNRI antidepressant drug\n\nDesvenlafaxine: Desvenlafaxine oral dose ranging from 50 to 100 mg/day'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo treatment\n\nPlacebo: Matching placebo pills'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.80', 'spread': '14.18', 'groupId': 'BG000'}, {'value': '36.28', 'spread': '11.65', 'groupId': 'BG001'}, {'value': '38.07', 'spread': '13.01', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': '59 met inclusion criteria and started with study medication.'}}, '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': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-07', 'studyFirstSubmitDate': '2012-02-16', 'resultsFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-09-07', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hamilton Rating Scale for Depression (HDRS24)', 'timeFrame': 'Baseline', 'description': 'HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression'}, {'measure': 'Hamilton Rating Scale for Depression (HDRS24)', 'timeFrame': 'Week 12', 'description': 'HDRS-24 total score, standardly used rating scale for depression. Score 0-7 no depression; Score 8-16 mild depression; Score 17-23 moderate depression; Score 24 and up severe depression. Range= 0 to 75, higher score=worse depression'}], 'secondaryOutcomes': [{'measure': 'Response Rate', 'timeFrame': '12 weeks', 'description': 'Assessment of overall improvement: based on HDRS and Clinical Global Improvement Scale Response Rate is defined as 50% improvement of Hamd24 summary scores from baseline.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dysthymic disorder', 'Dysthymia', 'Chronic non-major depression', 'Non-major chronic depression', 'Chronic depressive disorder', 'Antidepressant treatment'], 'conditions': ['Dysthymic Disorder', 'Dysthymia', 'Chronic Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '17503976', 'type': 'BACKGROUND', 'citation': 'DeMartinis NA, Yeung PP, Entsuah R, Manley AL. A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder. J Clin Psychiatry. 2007 May;68(5):677-88. doi: 10.4088/jcp.v68n0504.'}, {'pmid': '21527126', 'type': 'BACKGROUND', 'citation': 'Levkovitz Y, Tedeschini E, Papakostas GI. Efficacy of antidepressants for dysthymia: a meta-analysis of placebo-controlled randomized trials. J Clin Psychiatry. 2011 Apr;72(4):509-14. doi: 10.4088/JCP.09m05949blu.'}, {'pmid': '36996664', 'type': 'DERIVED', 'citation': 'Bansal R, Hellerstein DJ, Sawardekar S, Chen Y, Peterson BS. A randomized controlled trial of desvenlafaxine-induced structural brain changes in the treatment of persistent depressive disorder. Psychiatry Res Neuroimaging. 2023 Jun;331:111634. doi: 10.1016/j.pscychresns.2023.111634. Epub 2023 Mar 24.'}, {'pmid': '35592490', 'type': 'DERIVED', 'citation': 'Yang J, Hellerstein DJ, Chen Y, McGrath PJ, Stewart JW, Peterson BS, Wang Z. Serotonin-norepinephrine reuptake inhibitor antidepressant effects on regional connectivity of the thalamus in persistent depressive disorder: evidence from two randomized, double-blind, placebo-controlled clinical trials. Brain Commun. 2022 Apr 15;4(3):fcac100. doi: 10.1093/braincomms/fcac100. eCollection 2022.'}, {'pmid': '30423468', 'type': 'DERIVED', 'citation': 'Hellerstein DJ, Stewart JW, Chen Y, Arunagiri V, Peterson BS, McGrath PJ. Desvenlafaxine vs. placebo in the treatment of persistent depressive disorder. J Affect Disord. 2019 Feb 15;245:403-411. doi: 10.1016/j.jad.2018.11.065. Epub 2018 Nov 5.'}], 'seeAlsoLinks': [{'url': 'http://www.depression-nyc.org', 'label': 'Depression Evaluation Service, NY State Psychiatric Institute website'}, {'url': 'http://sklad.cumc.columbia.edu/psychiatry/clinical_trials/View_Trial.php?ID=366&type=simple', 'label': 'Columbia Psychiatry website, clinical trials'}]}, 'descriptionModule': {'briefSummary': "The investigators are studying a new antidepressant medicine, desvenlafaxine, for the treatment of people with chronic depression. Desvenlafaxine (trade name Pristiq) has been approved by the FDA for the treatment of major depression.\n\nThe investigators are testing whether this medicine is also effective for adults with a type of chronic depression that is less severe than major depression. This condition is also known as dysthymic disorder or dysthymia. Chronic depression, lasting two or more years, often causes significant suffering and impairment.\n\nIn addition, the investigators are using MRI imaging, which uses magnetic signals to make pictures of the brain's structure and also of its functioning. The purpose of MRI imaging in this study is to see whether chronic depression is associated with differences in brain structure or functioning, and whether such differences change after medication or placebo treatment. To test this MRI scans are done at the start of the study and after 12 weeks of medication or placebo treatment. Getting MRI imaging will be an option for participants in this study but is not required.\n\nThis study involves a 6 to 12 week double-blind period during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the double blind phase, all subjects can be treated for 12 weeks with an FDA-approved antidepressant medication.\n\nAssessments (of depressive symptoms, social functioning, and personality) will be done by study staff and by patients before the study starts, at each study visit for the first 12 weeks, and again after 24 weeks in the study.", 'detailedDescription': 'The investigators wish to study acute efficacy for 12 weeks on a double blind basis and continued response after open-label treatment at week 24 follow-up. It is important to establish the acute (12 week) efficacy of desvenlafaxine in non-major chronic depression. Also, given that non-major chronic depression is by definition chronic, it is important to demonstrate that benefit persists at follow-up assessment (24 weeks); this is clinically important in trying to alleviate the significant psychosocial morbidity associated with this disorder.\n\nThe investigators believe this study will have significant value in the treatment of patients with non-major chronic depression, and will add significantly to what remains an extremely small scientific literature.\n\nThe investigators would also like to study the effects of desvenlafaxine on brain structure and function. Learning that a medication reduces symptoms does not teach us how the medication achieves this outcome. Participants in this study can have the opportunity to participate in MRI scanning that will help to understand the mechanisms by with desvenlafaxine is effective. MRI scans are done prior to starting the clinical trial and then again after completing the double blind clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female outpatients 20 to 65 years of age, inclusive\n* Principal DSM-5 diagnosis of unipolar non-major Chronic Depressive Disorder (including Major Depression in partial remission, Major Depression, residual, Dysthymic Disorder, or Depressive Disorder NOS)\n* Minimum of 2 years duration of the current episode of depressive disorder.\n* Score of 12 or higher on the Hamilton Depression Scale (24 items) at baseline\n\nExclusion Criteria:\n\n* Full remission of depression in past 24 months\n* Current major depression diagnosis, psychotic illness\n* Current risk of suicide\n* Drug or alcohol abuse/dependence in past 6 months\n* Active medical illness\n* Prior nonresponse to desvenlafaxine\n* Medical illness contraindicating use of desvenlafaxine\n* Current or planned pregnancy during study period'}, 'identificationModule': {'nctId': 'NCT01537068', 'briefTitle': 'Desvenlafaxine vs. Placebo Treatment of Chronic Depression', 'organization': {'class': 'OTHER', 'fullName': 'New York State Psychiatric Institute'}, 'officialTitle': 'Desvenlafaxine (Pristiq) vs. Placebo in the Treatment of Chronic Depression', 'orgStudyIdInfo': {'id': '#6457 Pfizer-WS1895577'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desvenlafaxine', 'description': 'Serotonin-norepinephrine reuptake inhibitors (SNRIs) antidepressant drug', 'interventionNames': ['Drug: Desvenlafaxine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Desvenlafaxine', 'type': 'DRUG', 'otherNames': ['Pristiq'], 'description': 'Desvenlafaxine oral dose ranging from 50 to 100 mg/day', 'armGroupLabels': ['Desvenlafaxine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Inactive comparator'], 'description': 'Matching placebo pills', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York State Psychiatric Institute/3 Columbus Circle Midtown', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Depression Evaluation Service (DES), New York State Psychiatric Institute, Columbia University Department of Psychiatry', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'David J Hellerstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York State Psychiatric Institute, Columbia University Department of Psychiatry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'New York State Psychiatric Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}