Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
NCT ID: NCT01369095
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
976 participants
INTERVENTIONAL
2011-07-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo
Duloxetine
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
Escitalopram
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Interventions
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Duloxetine
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C\&D)
Escitalopram
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C\&D)
BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B\&C)
BMS-820836
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
BMS-820836
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
BMS-820836
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
BMS-820836
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Patients who have failed Duloxetine and Escitalopram at an adequate dose and for an adequate duration in their current episode.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, United States
Catalina Research Institute, Llc
Chino, California, United States
Behavioral Research Specialists, Llc
Glendale, California, United States
Pacific Clinical Research Medical Group
Orange, California, United States
Anderson Clinical Research
Redlands, California, United States
Affiliated Research Institute
San Diego, California, United States
Artemis Institute For Clinical Research
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
Western Affiliated Research Institute
Denver, Colorado, United States
Connecticut Clinical Research
Cromwell, Connecticut, United States
Meridien Research
Brooksville, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Amit Vijapura
Jacksonville, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Uptown Research Institute, Llc
Chicago, Illinois, United States
Clinco
Terre Haute, Indiana, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States
Ert
Shreveport, Louisiana, United States
Mclean Hospital
Belmont, Massachusetts, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States
Comprehensive Clinical Development, Inc
Fresh Meadows, New York, United States
Bioscience Research, Llc
Mount Kisco, New York, United States
Village Clinical Research, Inc.
New York, New York, United States
Northcoast Clinical Trials, Inc
Beachwood, Ohio, United States
Patient Priority Clinical Sites, Llc
Cincinnati, Ohio, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, United States
Suburban Research Associates
Media, Pennsylvania, United States
Keystone Clinical Studies, Llc
Norristown, Pennsylvania, United States
Ert
Pittsburgh, Pennsylvania, United States
Neuropsychiatric Research Center Of Orange County
Pittsburgh, Pennsylvania, United States
Northwest Clinical Research Center
Pittsburgh, Pennsylvania, United States
Lincoln Research
Lincoln, Rhode Island, United States
Future Search Trials
Austin, Texas, United States
Futuresearch Trials Of Dallas
Dallas, Texas, United States
Insite Clinical Research
DeSoto, Texas, United States
Ben Taub General Hospital
Houston, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Ericksen Research And Development
Clinton, Utah, United States
Clinical Methods Llc
Murray, Utah, United States
Neuropsychiatric Associates
Woodstock, Vermont, United States
Neuroscience, Inc
Herndon, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Local Institution
Caba, Buenos Aires, Argentina
Local Institution
Caba, Buenos Aires, Argentina
Local Institution
La Plata, Buenos Aires, Argentina
Local Institution
Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
Local Institution
Mendoza, Mendoza Province, Argentina
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Brisbane, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Heidelberg, Victoria, Australia
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Nedlands, Western Australia, Australia
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Vienna, , Austria
Local Institution
Vienna, , Austria
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Vancouver, British Columbia, Canada
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Bathurst, New Brunswick, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montpellier, France, France
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Dole, , France
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Douai, , France
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Élancourt, , France
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Jonzac, , France
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Tirupati, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Mumbai, Maharashtra, India
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Pune, Maharashtra, India
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Lucknow, Uttar Pradesh, India
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Chennai, , India
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Pune, , India
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Varanasi, , India
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Pisa, , Italy
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Roma, , Italy
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Siena, , Italy
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Ponce, , Puerto Rico
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Pretoria, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Durban, KwaZulu-Natal, South Africa
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
London, Greater London, United Kingdom
Local Institution
Edgware, Middlesex, United Kingdom
Local Institution
Birmingham, West Midlands, United Kingdom
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-000778-71
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN162-007
Identifier Type: -
Identifier Source: org_study_id
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