Study Stopped
Failure to meet primary endpoint
Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression
2 other identifiers
interventional
789
11 countries
140
Brief Summary
The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.
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 Aug 2011
140 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
May 25, 2011
CompletedFirst Posted
Study publicly available on registry
May 27, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedOctober 12, 2015
September 1, 2015
2.2 years
May 25, 2011
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Long-term effects of BMS-820836 on blood pressure in patients with depression
Baseline through Week 54
Secondary Outcomes (1)
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
Baseline through Week 54
Study Arms (3)
Arm 1: Placebo + BMS-820836 (0.5 mg/day)
EXPERIMENTALArm 2: Placebo + BMS-820836 (1 mg/day)
EXPERIMENTALArm 3: Placebo + BMS-820836 (2 mg/day)
EXPERIMENTALInterventions
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (144)
Birmingham Psychiatry Pharmaceutical Studies, Inc.
Birmingham, Alabama, 35226, United States
K & S Professional Research Services, Llc
Little Rock, Arkansas, 72201, United States
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
Little Rock, Arkansas, 72223, United States
Pacific Clinical Research Medical Group
Arcadia, California, 91007, United States
Catalina Research Institute, Llc
Chino, California, 91710, United States
Pharmacology Research Institute
Encino, California, 91316, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Behavioral Research Specialists, Llc
Glendale, California, 91206, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Newport Beach, California, 92660, United States
Neuropsychiatric Research Center Of Orange County
Orange, California, 92868, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
Anderson Clinical Research
Redlands, California, 92374, United States
California Neuropsychopharmacology Clinical
San Diego, California, 92102, United States
Pacific Research Network
San Diego, California, 92103, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Artemis Institute For Clinical Research
San Diego, California, 92123, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, 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
Western Affiliated Research Institute
Denver, Colorado, 80209, United States
Radiant Research, Inc.
Denver, Colorado, 80239, United States
Connecticut Clinical Research
Cromwell, Connecticut, 06416, United States
Meridien Research
Brooksville, Florida, 34601, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912, United States
Amit Vijapura
Jacksonville, Florida, 32256, 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
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407, United States
Emory University
Atlanta, Georgia, 30306, 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 Medical Center
Maywood, Illinois, 60153, United States
Alpine Clinic
Lafayette, Indiana, 47905, United States
Clinco
Terre Haute, Indiana, 47802, United States
Clinical Trials Technology, Inc
Prairie Village, Kansas, 66206, United States
James G. Barbee, Md, Llc
New Orleans, Louisiana, 70115, United States
J. Gary Booker, Md, Apmc
Shreveport, Louisiana, 71104, United States
Mclean Hospital
Belmont, Massachusetts, 02478, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87109, United States
Spri Clinical Trials, Llc
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Comprehensive Clinical Development, Inc
Jamaica, New York, 11432, United States
Village Clinical Research, Inc.
New York, New York, 10003, United States
Finger Lakes Clinical Research
Rochester, New York, 14618, United States
Carolinas Healthcare System
Charlotte, North Carolina, 28203, United States
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, 27609, United States
Northcoast Clinical Trials, Inc
Beachwood, Ohio, 44122, United States
Patient Priority Clinical Sites, Llc
Cincinnati, Ohio, 45215, United States
Midwest Clinical Research Center
Dayton, Ohio, 45417, United States
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623, 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
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Keystone Clinical Studies, Llc
Norristown, Pennsylvania, 19403, United States
Univ Of Penn
Philadelphia, Pennsylvania, 19104-3309, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104-3309, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Comprehensive Psychiatric Care
Pittsburgh, Pennsylvania, 06360, United States
Bioscience Research, Llc
Pittsburgh, Pennsylvania, 15219, United States
Insite Clinical Research
Pittsburgh, Pennsylvania, 15219, United States
Lincoln Research
Lincoln, Rhode Island, 02865, United States
Carolina Clinical Research Services
Columbia, South Carolina, 29201, United States
Psychiatric Consultants, Pc
Franklin, Tennessee, 37067, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Futuresearch Trials
Austin, Texas, 78731, United States
Community Clinical Research, Inc.
Austin, Texas, 78754, United States
Futuresearch Trials Of Dallas
Dallas, Texas, 75231, United States
Baylor College Of Medicine
Houston, Texas, 77030, United States
Ut Health-Houston
Houston, Texas, 77054, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090, United States
San Antonio Psychiatric Research Center
San Antonio, Texas, 78229, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Ericksen Research And Development
Clinton, Utah, 84015, United States
Radiant Research, Inc.
Murray, Utah, 84123, United States
Psychiatric And Behavioral Solutions
Salt Lake City, Utah, 84105, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Neuropsychiatric Associates
Woodstock, Vermont, 05091, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, 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
Caba, Buenos Aires, 1405, Argentina
Local Institution
Caba, Buenos Aires, 1425, Argentina
Local Institution
La Plata, Buenos Aires, 1900, Argentina
Local Institution
Córdoba, Córdoba Province, 5000, Argentina
Local Institution
Córdoba, Córdoba Province, 5003, Argentina
Local Institution
Mendoza, Mendoza Province, 5500, Argentina
Local Institution
Brisbane, Queensland, 4000, Australia
Local Institution
Adelaide, South Australia, 5112, Australia
Local Institution
Heidelberg, Victoria, 3084, Australia
Local Institution
Nedlands, Western Australia, 6009, Australia
Local Institution
Vienna, 1010, Austria
Local Institution
Vienna, 1090, Austria
Local Institution
Helsinki, 00100, Finland
Local Institution
Helsinki, 00260, Finland
Local Institution
Jarvenpaa, 04400, Finland
Local Institution
Oulu, 90100, Finland
Local Institution
Seinäjoki, 60100, Finland
Local Institution
Tampere, 33200, Finland
Local Institution
Turku, 20100, Finland
Local Institution
Montpellier, France, 34295, France
Local Institution
Paris, France, 75012, France
Local Institution
Dole, 39108, France
Local Institution
Douai, 59500, France
Local Institution
Élancourt, 78990, France
Local Institution
Jonzac, 17503, France
Local Institution
Limoges, 87025, France
Local Institution
Ahmedabad, Gujarat, 380 006, India
Local Institution
Mumbai, Maharashtra, 400012, India
Local Institution
Pune, Maharashtra, 411004, India
Local Institution
Chennai, 600116, India
Local Institution
Pune, 411030, India
Local Institution
Varanasi, 211 005, India
Local Institution
Vishakapattanam, 530002, India
Local Institution
Pisa, 56100, Italy
Local Institution
Siena, 53100, Italy
Local Institution
Ponce, 00730, Puerto Rico
Local Institution
Johannesburg, Gauteng, 2195, South Africa
Local Institution
Pretoria, Gauteng, 0002, South Africa
Local Institution
Pretoria, Gauteng, 0181, South Africa
Local Institution
Pretoria, Gauteng, 0187, South Africa
Local Institution
Durban, KwaZulu-Natal, 3630, South Africa
Local Institution
Cape Town, Western Cape, 7530, South Africa
Local Institution
Arganda, 28500, Spain
Local Institution
Barcelona, 08003, Spain
Local Institution
Barcelona, 08025, Spain
Local Institution
Madrid, 28006, Spain
Local Institution
Halmstad, 302 48, Sweden
Local Institution
Kungens Kurva, 14175, Sweden
Local Institution
Lund, 22222, Sweden
Local Institution
Uppsala, 751 85, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2011
First Posted
May 27, 2011
Study Start
August 1, 2011
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-09