Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression
2 other identifiers
interventional
889
6 countries
84
Brief Summary
The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued duloxetine 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 Apr 2011
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 12, 2015
September 1, 2015
1.8 years
February 15, 2011
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
End of phase B and End of phase C
Secondary Outcomes (2)
Change in Sheehan Disability Scale (SDS) Total score
End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
End of Phase B and End of Phase C
Study Arms (5)
Arm 1: Duloxetine 30mg
ACTIVE COMPARATORArm 2: BMS-820836 placebo
PLACEBO COMPARATORArm 3: BMS-820836 0.5-2.0 mg/day
EXPERIMENTALArm 4: Duloxetine 30mg
ACTIVE COMPARATORArm 5: Duloxetine placebo
PLACEBO COMPARATORInterventions
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.
- Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (84)
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201, United States
Pacific Clinical Research Medical Group
Arcadia, California, 91007, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, 92102, United States
Pacific Research Network, Inc
San Diego, California, 92103, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Compass Research, Llc
Orlando, Florida, 32806, United States
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, 33716, United States
Atlanta Institute Of Medicine & Research
Atlanta, Georgia, 30328, United States
Comprehensive Clinical Development, Inc.
Atlanta, Georgia, 30328, United States
Carman Research
Smyrna, Georgia, 30080, United States
Loyola University Health System
Maywood, Illinois, 60153, United States
Alpine Clinic
Lafayette, Indiana, 47905, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206, United States
James G. Barbee, Md, Llc
New Orleans, Louisiana, 70115, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, 27609, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Ips Research Company
Oklahoma City, Oklahoma, 73103, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Portland, Oregon, 97210, United States
Summit Research Network (Oregon) Inc
Portland, Oregon, 97210, United States
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
Salem, Oregon, 97301, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, 18104, United States
Univ Of Penn
Philadelphia, Pennsylvania, 19104, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, 19131, United States
University Of Pennsylvania
Philadephia, Pennsylvania, 19104, United States
Carolina Clinical Research Services
Columbia, South Carolina, 29201, United States
University Of South Carolina School Of Medicine
Columbia, South Carolina, 29203, United States
Psychiatric Consultants, Pc
Franklin, Tennessee, 37067, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Uthealth - Houston
Houston, Texas, 77054, United States
Red Oak Psychiatry Associates
Houston, Texas, 77090, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, 78229, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Psychiatric And Behavioral Solutions
Salt Lake City, Utah, 84105, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, 98104, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
Independent Psychiatric Consultants, Sc, Dba, Ipc Research
Waukesha, Wisconsin, 53188, United States
Local Institution
Edmonton, Alberta, T6L 6W6, Canada
Local Institution
Vancouver, British Columbia, V6T 2A1, Canada
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Toronto, Ontario, M5g 2n2, Canada
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Montreal, Quebec, H4H 1R3, Canada
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Québec, Quebec, G3K 2P8, Canada
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Helsinki, 00100, Finland
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Helsinki, 00260, Finland
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Jarvenpaa, 04400, Finland
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Oulu, 90100, Finland
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Seinäjoki, 60100, Finland
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Tampere, 33200, Finland
Local Institution
Turku, 20100, Finland
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Montpellier, France, 34295, France
Local Institution
Nîmes, France, 30900, France
Local Institution
Paris, France, 75012, France
Local Institution
Dole, 39100, France
Local Institution
Douai, 59500, France
Local Institution
Élancourt, 78990, France
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Limoges, 87025, France
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Johannesburg, Gauteng, 2195, South Africa
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Pretoria, Gauteng, 0183, South Africa
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Vereeniging, Gauteng, 1939, South Africa
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Bellville, Western Cape, 7535, South Africa
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Cape Town, Western Cape, 7530, South Africa
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Somerset West, Western Cape, 7130, South Africa
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Halmstad, 302 48, Sweden
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Kungens Kurva, 141 75, Sweden
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Lund, 222 22, Sweden
Local Institution
Uppsala, 751 85, Sweden
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
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2011
First Posted
March 7, 2011
Study Start
April 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-09