- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309945
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
September 23, 2015 updated by: Bristol-Myers Squibb
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
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).
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
889
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G3K 2P8
- Local Institution
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Alberta
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Edmonton, Alberta, Canada, T6L 6W6
- Local Institution
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2A1
- Local Institution
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Ontario
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Toronto, Ontario, Canada, M5G 2N2
- Local Institution
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Quebec
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Montreal, Quebec, Canada, H4H 1R3
- Local Institution
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Helsinki, Finland, 00100
- Local Institution
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Helsinki, Finland, 00260
- Local Institution
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Jarvenpaa, Finland, 04400
- Local Institution
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Oulu, Finland, 90100
- Local Institution
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Seinajoki, Finland, 60100
- Local Institution
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Tampere, Finland, 33200
- Local Institution
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Turku, Finland, 20100
- Local Institution
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Dole, France, 39100
- Local Institution
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Douai, France, 59500
- Local Institution
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Elancourt, France, 78990
- Local Institution
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Limoges Cedex, France, 87025
- Local Institution
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Montpellier Cedex 5, France, 34295
- Local Institution
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Nimes, France, 30900
- Local Institution
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Paris, France, 75012
- Local Institution
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Gauteng
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Johannesburg, Gauteng, South Africa, 2195
- Local Institution
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Pretoria, Gauteng, South Africa, 0183
- Local Institution
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Vereeniging, Gauteng, South Africa, 1939
- Local Institution
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Western Cape
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Bellville, Western Cape, South Africa, 7535
- Local Institution
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Cape Town, Western Cape, South Africa, 7530
- Local Institution
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Somerset West, Western Cape, South Africa, 7130
- Local Institution
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Halmstad, Sweden, 302 48
- Local Institution
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Kungens Kurva, Sweden, 141 75
- Local Institution
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Lund, Sweden, 222 22
- Local Institution
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Uppsala, Sweden, 751 85
- Local Institution
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Arkansas
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Little Rock, Arkansas, United States, 72201
- K & S Professional Research Services, LLC
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California
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Arcadia, California, United States, 91007
- Pacific Clinical Research Medical Group
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Encino, California, United States, 91316
- Pharmacology Research Institute
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Network, Inc.
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Los Alamitos, California, United States, 90720
- Pharmacology Research Institute
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Newport Beach, California, United States, 92660
- Pharmacology Research Institute
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San Diego, California, United States, 92103
- Pacific Research Network, Inc
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San Diego, California, United States, 92102
- California Neuropsychopharmacology Clinical Research Inst.
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Sherman Oaks, California, United States, 91403
- California Neuroscience Research Medical Group, inc.
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Sherman Oaks, California, United States, 91403
- Schuster Medical Research Institute
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Upland, California, United States, 91786
- Pacific Clinical Research Medical Group
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Colorado
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Denver, Colorado, United States, 80239
- Radiant Research, Inc.
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Connecticut
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Norwich, Connecticut, United States, 06360
- Comprehensive Psychiatric Care
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Florida
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Jacksonville, Florida, United States, 32256
- Clinical Neuroscience Solutions, Inc.
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Orlando, Florida, United States, 32806
- Compass Research, LLC
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Orlando, Florida, United States, 32806
- Clinical Neuroscience Solutions, Inc.
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St Petersburg, Florida, United States, 33716
- Comprehensive Clinical Development, Inc.
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Georgia
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Atlanta, Georgia, United States, 30328
- Atlanta Institute of Medicine & Research
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Atlanta, Georgia, United States, 30328
- Comprehensive Clinical Development, Inc.
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Smyrna, Georgia, United States, 30080
- Carman Research
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Illinois
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Maywood, Illinois, United States, 60153
- Loyola University Health System
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Indiana
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Lafayette, Indiana, United States, 47905
- Alpine Clinic
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Kansas
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Prairie Village, Kansas, United States, 66206
- Clinical Trials Technology, Inc
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Louisiana
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New Orleans, Louisiana, United States, 70115
- James G. Barbee, Md, Llc
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New York
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Brooklyn, New York, United States, 11235
- SPRI Clinical Trials, LLC
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Cedarhurst, New York, United States, 11516
- Neurobehavioral Research, Inc.
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Rochester, New York, United States, 14618
- Finger Lakes Clinical Research
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North Carolina
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Raleigh, North Carolina, United States, 27609
- Richard H. Weisler, Md, Pa & Assoc.
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Ohio
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Dayton, Ohio, United States, 45417
- Midwest Clinical Research Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- IPS Research Company
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Tulsa, Oklahoma, United States, 74104
- Tulsa Clinical Research, LLC
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Oregon
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Portland, Oregon, United States, 97210
- Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
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Portland, Oregon, United States, 97210
- Summit Research Network (Oregon) Inc
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Salem, Oregon, United States, 97301
- Oregon Center For Clinical Investigations, Inc (Occi, Inc)
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Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Lehigh Center for Clinical Research
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, United States, 19131
- Belmont Center For Comprehensive Treatment
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Philadelphia, Pennsylvania, United States, 19104
- Univ Of Penn
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Philadephia, Pennsylvania, United States, 19104
- University of Pennsylvania
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South Carolina
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Columbia, South Carolina, United States, 29203
- University of South Carolina School of Medicine
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Columbia, South Carolina, United States, 29201
- Carolina Clinical Research Services
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Tennessee
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Franklin, Tennessee, United States, 37067
- Psychiatric Consultants, PC
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions, Inc.
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Texas
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Austin, Texas, United States, 78754
- Community Clinical Research, Inc.
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Houston, Texas, United States, 77090
- Red Oak Psychiatry Associates
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Houston, Texas, United States, 77054
- Uthealth - Houston
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San Antonio, Texas, United States, 78229
- San Antonio Psychiatric Research Center
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Utah
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Murray, Utah, United States, 84123
- Radiant Research, Inc.
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Salt Lake City, Utah, United States, 84105
- Psychiatric and Behavioral Solutions
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Washington
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Bellevue, Washington, United States, 98004
- Northwest Clinical Research Center
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Seattle, Washington, United States, 98104
- Summit Research Network (Seattle) Llc
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Wisconsin
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Brown Deer, Wisconsin, United States, 53223
- Northbrooke Research Center
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Middleton, Wisconsin, United States, 53562
- Dean Foundation For Health Research & Education
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Waukesha, Wisconsin, United States, 53188
- Independent Psychiatric Consultants, Sc, Dba, Ipc Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Arm 1: Duloxetine 30mg
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Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Names:
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Names:
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Placebo Comparator: Arm 2: BMS-820836 placebo
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Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
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Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day
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Tablet, Oral, 0.5-2.0
mg, once daily (QD), 6 weeks
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Active Comparator: Arm 4: Duloxetine 30mg
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Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Names:
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Names:
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Placebo Comparator: Arm 5: Duloxetine placebo
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Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Time Frame: End of phase B and End of phase C
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End of phase B and End of phase C
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Sheehan Disability Scale (SDS) Total score
Time Frame: End of Phase B and End of Phase C
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End of Phase B and End of Phase C
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Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Time Frame: End of Phase B and End of Phase C
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End of Phase B and End of Phase C
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
February 15, 2011
First Submitted That Met QC Criteria
March 4, 2011
First Posted (Estimate)
March 7, 2011
Study Record Updates
Last Update Posted (Estimate)
October 12, 2015
Last Update Submitted That Met QC Criteria
September 23, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
Other Study ID Numbers
- CN162-006
- 2010-022841-93 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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