Viewing Study NCT01369095


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Ignite Modification Date: 2025-12-25 @ 9:52 PM
Study NCT ID: NCT01369095
Status: COMPLETED
Last Update Posted: 2015-10-12
First Post: 2011-06-07
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'C000594001', 'term': '6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 976}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2011-06-07', 'dispFirstSubmitQcDate': '2015-09-23', 'studyFirstSubmitQcDate': '2011-06-07', 'dispFirstPostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score', 'timeFrame': 'Week 13'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.', 'timeFrame': 'Week 13'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)\n* Patients must be able to understand the nature of the study, agree to comply with the prescribed dosage regimens, report for regularly scheduled office visits, and communicate to study personnel about adverse events and concomitant medication use.\n* Patients with a diagnosis of Major Depressive Disorder, currently experiencing a Major Depressive Episode, as defined by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (Text Revision)\\[DSM IV TR\\] criteria. The current depressive episode must be \\> 8 weeks in duration and \\< 3 years duration.\n* In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.\n* Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.\n\nExclusion Criteria:\n\n* Patients who report an inadequate response (less than 50% reduction in depressive symptom severity) to more than three adequate trials of antidepressant treatments during the current depressive episode.\n* Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.'}, 'identificationModule': {'nctId': 'NCT01369095', 'briefTitle': 'Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).', 'orgStudyIdInfo': {'id': 'CN162-007'}, 'secondaryIdInfos': [{'id': '2011-000778-71', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo', 'interventionNames': ['Drug: Duloxetine', 'Drug: Escitalopram', 'Drug: BMS-820836 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo', 'interventionNames': ['Drug: BMS-820836 Placebo', 'Drug: BMS-820836']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo', 'interventionNames': ['Drug: BMS-820836 Placebo', 'Drug: BMS-820836']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo', 'interventionNames': ['Drug: BMS-820836 Placebo', 'Drug: BMS-820836']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo', 'interventionNames': ['Drug: BMS-820836 Placebo', 'Drug: BMS-820836']}], 'interventions': [{'name': 'Duloxetine', 'type': 'DRUG', 'otherNames': ['Cymbalta'], 'description': 'Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\\&D)', 'armGroupLabels': ['Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo']}, {'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro'], 'description': 'Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\\&D)', 'armGroupLabels': ['Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo']}, {'name': 'BMS-820836 Placebo', 'type': 'DRUG', 'description': 'Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\\&C)', 'armGroupLabels': ['Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo', 'Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo', 'Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo', 'Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo', 'Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)', 'armGroupLabels': ['Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)', 'armGroupLabels': ['Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)', 'armGroupLabels': ['Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)', 'armGroupLabels': ['Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 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