Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
- Conditions
- Depression
- Interventions
- Registration Number
- NCT01361555
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 789
- Men and women of age 18-65 years (Argentina the minimum age will be 24 years of age)
- Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.
- Patient not randomized in parent study that meet inadequate response criteria
- Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.
- Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].
- In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3: Placebo + BMS-820836 (2 mg/day) BMS-820836 - Arm 1: Placebo + BMS-820836 (0.5 mg/day) Placebo matching with BMS-820836 - Arm 2: Placebo + BMS-820836 (1 mg/day) Placebo matching with BMS-820836 - Arm 2: Placebo + BMS-820836 (1 mg/day) BMS-820836 - Arm 3: Placebo + BMS-820836 (2 mg/day) Placebo matching with BMS-820836 - Arm 1: Placebo + BMS-820836 (0.5 mg/day) BMS-820836 -
- Primary Outcome Measures
Name Time Method Long-term effects of BMS-820836 on blood pressure in patients with depression Baseline through Week 54
- Secondary Outcome Measures
Name Time Method • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs Baseline through Week 54
Trial Locations
- Locations (86)
Red Oak Psychiatry Associates, Pa
🇺🇸Houston, Texas, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Schuster Medical Research Institute
🇺🇸Sherman Oaks, California, United States
Futuresearch Trials Of Dallas
🇺🇸Dallas, Texas, United States
Carolinas Healthcare System
🇺🇸Charlotte, North Carolina, United States
Richard H. Weisler, Md, Pa & Assoc.
🇺🇸Raleigh, North Carolina, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Behavioral Research Specialists, Llc
🇺🇸Glendale, California, United States
Neuropsychiatric Research Center Of Orange County
🇺🇸Orange, California, United States
Anderson Clinical Research
🇺🇸Redlands, California, United States
Atlanta Institute Of Medicine & Research
🇺🇸Atlanta, Georgia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Northcoast Clinical Trials, Inc
🇺🇸Beachwood, Ohio, United States
Lehigh Center For Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Univ Of Penn
🇺🇸Philadelphia, Pennsylvania, United States
Psychiatric Consultants, Pc
🇺🇸Franklin, Tennessee, United States
Community Clinical Research, Inc.
🇺🇸Austin, Texas, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Compass Research, Llc
🇺🇸Orlando, Florida, United States
Janus Center For Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Comprehensive Clinical Development, Inc.
🇺🇸Saint Petersburg, Florida, United States
Amit Vijapura
🇺🇸Jacksonville, Florida, United States
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
🇺🇸Salem, Oregon, United States
Gulfcoast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Birmingham Psychiatry Pharmaceutical Studies, Inc.
🇺🇸Birmingham, Alabama, United States
Artemis Institute For Clinical Research
🇺🇸San Diego, California, United States
Sharp Mesa Vista Hospital
🇺🇸San Diego, California, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
🇺🇸Portland, Oregon, United States
Ips Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc
🇺🇸Portland, Oregon, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
San Antonio Psychiatric Research Center
🇺🇸San Antonio, Texas, United States
Clinco
🇺🇸Terre Haute, Indiana, United States
Local Institution
🇸🇪Uppsala, Sweden
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
California Neuropsychopharmacology Clinical
🇺🇸San Diego, California, United States
K & S Professional Research Services, Llc
🇺🇸Little Rock, Arkansas, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
🇺🇸Little Rock, Arkansas, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Catalina Research Institute, Llc
🇺🇸Chino, California, United States
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Western Affiliated Research Institute
🇺🇸Denver, Colorado, United States
Connecticut Clinical Research
🇺🇸Cromwell, Connecticut, United States
Alpine Clinic
🇺🇸Lafayette, Indiana, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Village Clinical Research, Inc.
🇺🇸New York, New York, United States
James G. Barbee, Md, Llc
🇺🇸New Orleans, Louisiana, United States
J. Gary Booker, Md, Apmc
🇺🇸Shreveport, Louisiana, United States
Comprehensive Clinical Development, Inc
🇺🇸Jamaica, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Mclean Hospital
🇺🇸Belmont, Massachusetts, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Patient Priority Clinical Sites, Llc
🇺🇸Cincinnati, Ohio, United States
Neurology & Neuroscience Center Of Ohio
🇺🇸Toledo, Ohio, United States
Spri Clinical Trials, Llc
🇺🇸Brooklyn, New York, United States
Tulsa Clinical Research, Llc
🇺🇸Tulsa, Oklahoma, United States
Comprehensive Psychiatric Care
🇺🇸Pittsburgh, Pennsylvania, United States
University Of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Keystone Clinical Studies, Llc
🇺🇸Norristown, Pennsylvania, United States
Bioscience Research, Llc
🇺🇸Pittsburgh, Pennsylvania, United States
Carolina Clinical Research Services
🇺🇸Columbia, South Carolina, United States
Insite Clinical Research
🇺🇸Pittsburgh, Pennsylvania, United States
Lincoln Research
🇺🇸Lincoln, Rhode Island, United States
Futuresearch Trials
🇺🇸Austin, Texas, United States
Baylor College Of Medicine
🇺🇸Houston, Texas, United States
Ut Health-Houston
🇺🇸Houston, Texas, United States
Psychiatric And Behavioral Solutions
🇺🇸Salt Lake City, Utah, United States
Summit Research Network (Seattle) Llc
🇺🇸Seattle, Washington, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Ericksen Research And Development
🇺🇸Clinton, Utah, United States
Independent Psychiatric Consultants, Sc, Dba, Ipc Research
🇺🇸Waukesha, Wisconsin, United States
Radiant Research, Inc.
🇺🇸Murray, Utah, United States
Clinical Trials Technology, Inc
🇺🇸Prairie Village, Kansas, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Neuropsychiatric Associates
🇺🇸Woodstock, Vermont, United States
Northbrooke Research Center
🇺🇸Brown Deer, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States