Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
NCT ID: NCT01309945
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
889 participants
INTERVENTIONAL
2011-04-30
2013-01-31
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
DOUBLE
Study Groups
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Arm 1: Duloxetine 30mg
Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Arm 2: BMS-820836 placebo
Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Arm 3: BMS-820836 0.5-2.0 mg/day
BMS-820836
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Arm 4: Duloxetine 30mg
Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Arm 5: Duloxetine placebo
Placebo matching with Duloxetine
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Interventions
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Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
BMS-820836
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Placebo matching with Duloxetine
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
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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K & S Professional Research Services, Llc
Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
Arcadia, California, United States
Pharmacology Research Institute
Encino, California, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States
Pharmacology Research Institute
Los Alamitos, California, United States
Pharmacology Research Institute
Newport Beach, California, United States
California Neuropsychopharmacology Clinical Research Inst.
San Diego, California, United States
Pacific Research Network, Inc
San Diego, California, United States
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Radiant Research, Inc.
Denver, Colorado, United States
Comprehensive Psychiatric Care
Norwich, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Compass Research, Llc
Orlando, Florida, United States
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, United States
Atlanta Institute Of Medicine & Research
Atlanta, Georgia, United States
Comprehensive Clinical Development, Inc.
Atlanta, Georgia, United States
Carman Research
Smyrna, Georgia, United States
Loyola University Health System
Maywood, Illinois, United States
Alpine Clinic
Lafayette, Indiana, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, United States
James G. Barbee, Md, Llc
New Orleans, Louisiana, United States
SPRI Clinical Trials, LLC
Brooklyn, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Ips Research Company
Oklahoma City, Oklahoma, United States
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Portland, Oregon, United States
Summit Research Network (Oregon) Inc
Portland, Oregon, United States
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
Salem, Oregon, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Univ Of Penn
Philadelphia, Pennsylvania, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Belmont Center For Comprehensive Treatment
Philadelphia, Pennsylvania, United States
University Of Pennsylvania
Philadephia, Pennsylvania, United States
Carolina Clinical Research Services
Columbia, South Carolina, United States
University Of South Carolina School Of Medicine
Columbia, South Carolina, United States
Psychiatric Consultants, Pc
Franklin, Tennessee, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Community Clinical Research, Inc.
Austin, Texas, United States
Uthealth - Houston
Houston, Texas, United States
Red Oak Psychiatry Associates
Houston, Texas, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, United States
Radiant Research, Inc.
Murray, Utah, United States
Psychiatric And Behavioral Solutions
Salt Lake City, Utah, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Summit Research Network (Seattle) Llc
Seattle, Washington, United States
Northbrooke Research Center
Brown Deer, Wisconsin, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Independent Psychiatric Consultants, Sc, Dba, Ipc Research
Waukesha, Wisconsin, United States
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Montreal, Quebec, Canada
Local Institution
Québec, Quebec, Canada
Local Institution
Helsinki, , Finland
Local Institution
Helsinki, , Finland
Local Institution
Järvenpää, , Finland
Local Institution
Oulu, , Finland
Local Institution
Seinäjoki, , Finland
Local Institution
Tampere, , Finland
Local Institution
Turku, , Finland
Local Institution
Montpellier, France, France
Local Institution
Nîmes, France, France
Local Institution
Paris, France, France
Local Institution
Dole, , France
Local Institution
Douai, , France
Local Institution
Élancourt, , France
Local Institution
Limoges, , France
Local Institution
Johannesburg, Gauteng, South Africa
Local Institution
Pretoria, Gauteng, South Africa
Local Institution
Vereeniging, Gauteng, South Africa
Local Institution
Bellville, Western Cape, South Africa
Local Institution
Cape Town, Western Cape, South Africa
Local Institution
Somerset West, Western Cape, South Africa
Local Institution
Halmstad, , Sweden
Local Institution
Kungens Kurva, , Sweden
Local Institution
Lund, , Sweden
Local Institution
Uppsala, , Sweden
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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2010-022841-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CN162-006
Identifier Type: -
Identifier Source: org_study_id
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