Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
- Conditions
- Depression
- Interventions
- Drug: Placebo matching with Duloxetine
- Registration Number
- NCT01309945
- Lead Sponsor
- Bristol-Myers Squibb
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 889
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 5: Duloxetine placebo Placebo matching with Duloxetine - Arm 4: Duloxetine 30mg Duloxetine - Arm 1: Duloxetine 30mg Duloxetine - Arm 2: BMS-820836 placebo Placebo matching with BMS-820836 - Arm 3: BMS-820836 0.5-2.0 mg/day BMS-820836 -
- Primary Outcome Measures
Name Time Method Change in Montgomery Asberg Depression Rating Scale (MADRS) total score End of phase B and End of phase C
- Secondary Outcome Measures
Name Time Method Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score End of Phase B and End of Phase C Change in Sheehan Disability Scale (SDS) Total score End of Phase B and End of Phase C
Trial Locations
- Locations (48)
Univ Of Penn
🇺🇸Philadelphia, Pennsylvania, United States
Psychiatric Consultants, Pc
🇺🇸Franklin, Tennessee, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
K & S Professional Research Services, Llc
🇺🇸Little Rock, Arkansas, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Radiant Research, Inc.
🇺🇸Murray, Utah, United States
Comprehensive Psychiatric Care
🇺🇸Norwich, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Compass Research, Llc
🇺🇸Orlando, Florida, United States
Loyola University Health System
🇺🇸Maywood, Illinois, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Alpine Clinic
🇺🇸Lafayette, Indiana, United States
James G. Barbee, Md, Llc
🇺🇸New Orleans, Louisiana, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Richard H. Weisler, Md, Pa & Assoc.
🇺🇸Raleigh, North Carolina, United States
Tulsa Clinical Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
🇺🇸Salem, Oregon, United States
University Of Pennsylvania
🇺🇸Philadephia, Pennsylvania, United States
Belmont Center For Comprehensive Treatment
🇺🇸Philadelphia, Pennsylvania, United States
Carolina Clinical Research Services
🇺🇸Columbia, South Carolina, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
University Of South Carolina School Of Medicine
🇺🇸Columbia, South Carolina, United States
Northwest Clinical Research Center
🇺🇸Bellevue, 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
🇸🇪Uppsala, Sweden
Clinical Trials Technology, Inc
🇺🇸Prairie Village, Kansas, United States
California Neuropsychopharmacology Clinical Research Inst.
🇺🇸San Diego, California, United States
Pacific Research Network, Inc
🇺🇸San Diego, California, United States
Comprehensive Clinical Development, Inc.
🇺🇸Atlanta, Georgia, United States
Atlanta Institute Of Medicine & Research
🇺🇸Atlanta, Georgia, United States
Ips Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
🇺🇸Portland, Oregon, United States
Summit Research Network (Oregon) Inc
🇺🇸Portland, Oregon, 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
Psychiatric And Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Summit Research Network (Seattle) Llc
🇺🇸Seattle, Washington, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Lehigh Center For Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States