Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
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).
2 other identifiers
interventional
976
11 countries
89
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 depression
Started Jul 2011
89 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2011
CompletedFirst Posted
Study publicly available on registry
June 8, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedOctober 12, 2015
September 1, 2015
1.8 years
June 7, 2011
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Week 13
Secondary Outcomes (1)
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Week 13
Study Arms (5)
Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo
ACTIVE COMPARATORArm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo
EXPERIMENTALArm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo
EXPERIMENTALArm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo
EXPERIMENTALArm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo
EXPERIMENTALInterventions
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Eligibility Criteria
You may qualify if:
- Men and women of age 18-65 years (Argentina minimum age will be 24 years of age)
- 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.
- 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.
- In the current Major depressive disorder (MDD) episode, patients should report a history of inadequate response to 1-3 adequate trials of antidepressant treatment.
- Patients must have a 17-item Hamilton Depression Rating Scale (HAM-D17) total score ≥ 18 at Screening and Baseline.
You may not qualify if:
- 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.
- Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (93)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
Catalina Research Institute, Llc
Chino, California, 91710, United States
Behavioral Research Specialists, Llc
Glendale, California, 91206, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
Anderson Clinical Research
Redlands, California, 92374, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Artemis Institute For Clinical Research
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Connecticut Clinical Research
Cromwell, Connecticut, 06416, United States
Meridien Research
Brooksville, Florida, 34601, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Amit Vijapura
Jacksonville, Florida, 32256, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30306, United States
Uptown Research Institute, Llc
Chicago, Illinois, 60640, United States
Clinco
Terre Haute, Indiana, 47802, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206, United States
Ert
Shreveport, Louisiana, 71104, United States
Mclean Hospital
Belmont, Massachusetts, 02478, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
Comprehensive Clinical Development, Inc
Fresh Meadows, New York, 11366, United States
Bioscience Research, Llc
Mount Kisco, New York, 10549, United States
Village Clinical Research, Inc.
New York, New York, 10003, United States
Northcoast Clinical Trials, Inc
Beachwood, Ohio, 44122, United States
Patient Priority Clinical Sites, Llc
Cincinnati, Ohio, 45215, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Keystone Clinical Studies, Llc
Norristown, Pennsylvania, 19403, United States
Ert
Pittsburgh, Pennsylvania, 15219, United States
Neuropsychiatric Research Center Of Orange County
Pittsburgh, Pennsylvania, 15219, United States
Northwest Clinical Research Center
Pittsburgh, Pennsylvania, 15219, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Future Search Trials
Austin, Texas, 78731, United States
Futuresearch Trials Of Dallas
Dallas, Texas, 75231, United States
Insite Clinical Research
DeSoto, Texas, 75115, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Ericksen Research And Development
Clinton, Utah, 84015, United States
Clinical Methods Llc
Murray, Utah, 84107, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Neuroscience, Inc
Herndon, Virginia, 20170, United States
Virginia Commonwealth University
Richmond, Virginia, 23219, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
Local Institution
Caba, Buenos Aires, 1405, Argentina
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Caba, Buenos Aires, 1425, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Córdoba, Córdoba Province, 5000, Argentina
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Córdoba, Córdoba Province, 5003, Argentina
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Mendoza, Mendoza Province, 5500, Argentina
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Brisbane, Queensland, 4000, Australia
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Adelaide, South Australia, 5112, Australia
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Heidelberg, Victoria, 3084, Australia
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Nedlands, Western Australia, 6009, Australia
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Vienna, 1010, Austria
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Vienna, 1090, Austria
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Vancouver, British Columbia, V6Z 2L4, Canada
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Bathurst, New Brunswick, E2A 4X7, Canada
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Ottawa, Ontario, K1Z 7K4, Canada
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Toronto, Ontario, M4W 2N4, Canada
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Montreal, Quebec, H1N 3V2, Canada
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Montreal, Quebec, H2R 1V6, Canada
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Montpellier, France, 34295, France
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Dole, 39100, France
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Douai, 59500, France
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Élancourt, 78990, France
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Jonzac, 175003, France
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Tirupati, Andhra Pradesh, 517 507, India
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Visakhapatnam, Andhra Pradesh, 530002, India
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Ahmedabad, Gujarat, 380 006, India
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Mumbai, Maharashtra, 400012, India
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Pune, Maharashtra, 411004, India
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Lucknow, Uttar Pradesh, 226006, India
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Chennai, 600116, India
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Pune, 411030, India
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Varanasi, 211 005, India
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Pisa, 56126, Italy
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Roma, 00168, Italy
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Siena, 53100, Italy
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Ponce, 00731, Puerto Rico
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Pretoria, Gauteng, 0002, South Africa
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Pretoria, Gauteng, 0181, South Africa
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Pretoria, Gauteng, 0187, South Africa
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Durban, KwaZulu-Natal, 3630, South Africa
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Barcelona, 08003, Spain
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Barcelona, 08025, Spain
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London, Greater London, W6 8RP, United Kingdom
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Edgware, Middlesex, HA8 0AD, United Kingdom
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Birmingham, West Midlands, B23 6DW, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2011
First Posted
June 8, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-09