Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

September 23, 2015 updated by: Bristol-Myers Squibb

A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

The purpose of this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

789

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

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution
      • Cordoba, Argentina, 5003
        • Local Institution
      • Mendoza, Argentina, 5500
        • Local Institution
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, 1405
        • Local Institution
      • Caba, Buenos Aires, Argentina, 1425
        • Local Institution
      • La Plata, Buenos Aires, Argentina, 1900
        • Local Institution
  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4000
        • Local Institution
    • South Australia
      • Adelaide, South Australia, Australia, 5112
        • Local Institution
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Austria
      • Wien, Austria, 1090
        • Local Institution
      • Wien, Austria, 1010
        • Local Institution
  • Finland
      • Helsinki, Finland, 00100
        • Local Institution
      • Helsinki, Finland, 00260
        • Local Institution
      • Jarvenpaa, Finland, 04400
        • Local Institution
      • Oulu, Finland, 90100
        • Local Institution
      • Seinajoki, Finland, 60100
        • Local Institution
      • Tampere, Finland, 33200
        • Local Institution
      • Turku, Finland, 20100
        • Local Institution
  • France
      • Dole, France, 39108
        • Local Institution
      • Douai, France, 59500
        • Local Institution
      • Elancourt, France, 78990
        • Local Institution
      • Jonzac, France, 17503
        • Local Institution
      • Limoges Cedex, France, 87025
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Paris, France, 75012
        • Local Institution
  • India
      • Chennai, India, 600116
        • Local Institution
      • Pune, India, 411030
        • Local Institution
      • Varanasi, India, 211 005
        • Local Institution
      • Vishakapattanam, India, 530002
        • Local Institution
    • Gujarat
      • Ahmedabad, Gujarat, India, 380 006
        • Local Institution
    • Maharashtra
      • Mumbai, Maharashtra, India, 400012
        • Local Institution
      • Pune, Maharashtra, India, 411004
        • Local Institution
  • Italy
      • Pisa, Italy, 56100
        • Local Institution
      • Siena, Italy, 53100
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico, 00730
        • Local Institution
  • South Africa
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2195
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0002
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0181
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0187
        • Local Institution
    • Kwa Zulu Natal
      • Durban, Kwa Zulu Natal, South Africa, 3630
        • Local Institution
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7530
        • Local Institution
  • Spain
      • Arganda Del Rey, Spain, 28500
        • Local Institution
      • Barcelona, Spain, 08003
        • Local Institution
      • Barcelona, Spain, 08025
        • Local Institution
      • Madrid, Spain, 28006
        • Local Institution
  • Sweden
      • Halmstad, Sweden, 302 48
        • Local Institution
      • Kungens Kurva, Sweden, 14175
        • Local Institution
      • Lund, Sweden, 22222
        • Local Institution
      • Uppsala, Sweden, 751 85
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35226
        • Birmingham Psychiatry Pharmaceutical Studies, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72223
        • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
      • Little Rock, Arkansas, United States, 72201
        • K & S Professional Research Services, LLC
    • California
      • Arcadia, California, United States, 91007
        • Pacific Clinical Research Medical Group
      • Chino, California, United States, 91710
        • Catalina Research Institute, LLC
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Glendale, California, United States, 91206
        • Behavioral Research Specialists, LLC
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Orange, California, United States, 92868
        • Pacific Clinical Research Medical Group
      • Orange, California, United States, 92868
        • Neuropsychiatric Research Center of Orange County
      • Redlands, California, United States, 92374
        • Anderson Clinical Research
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Diego, California, United States, 92123
        • Sharp Mesa Vista Hospital
      • San Diego, California, United States, 92123
        • Artemis Institute for Clinical Research
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Colorado
      • Denver, Colorado, United States, 80209
        • Western Affiliated Research Institute
      • Denver, Colorado, United States, 80239
        • Radiant Research, Inc.
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Connecticut Clinical Research
    • Florida
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Fort Myers, Florida, United States, 33912
        • Gulfcoast Clinical Research Center
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Jacksonville, Florida, United States, 32256
        • Amit Vijapura
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • Saint Petersburg, Florida, United States, 33716
        • Comprehensive Clinical Development, Inc.
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine & Research
      • Atlanta, Georgia, United States, 30306
        • Emory University
      • Atlanta, Georgia, United States, 30328
        • Comprehensive Clinical Development, Inc
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Alpine Clinic
      • Terre Haute, Indiana, United States, 47802
        • Clinco
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Clinical Trials Technology, Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • James G. Barbee, Md, Llc
      • Shreveport, Louisiana, United States, 71104
        • J. Gary Booker, MD, APMC
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience, Inc.
    • New York
      • Brooklyn, New York, United States, 11235
        • SPRI Clinical Trials, LLC
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • Jamaica, New York, United States, 11432
        • Comprehensive Clinical Development, Inc
      • New York, New York, United States, 10003
        • Village Clinical Research, Inc.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Healthcare System
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, Md, Pa & Assoc.
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Northcoast Clinical Trials, Inc
      • Cincinnati, Ohio, United States, 45215
        • Patient Priority Clinical Sites, LLC
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
      • Portland, Oregon, United States, 97210
        • Summit Research Network (Oregon) Inc
      • Salem, Oregon, United States, 97301
        • Oregon Center For Clinical Investigations, Inc (Occi, Inc)
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Norristown, Pennsylvania, United States, 19403
        • Keystone Clinical Studies, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • Univ Of Penn
      • Pittsburgh, Pennsylvania, United States, 06360
        • Comprehensive Psychiatric Care
      • Pittsburgh, Pennsylvania, United States, 15219
        • Bioscience Research, LLC
      • Pittsburgh, Pennsylvania, United States, 15219
        • InSite Clinical Research
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Lincoln Research
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Carolina Clinical Research Services
    • Tennessee
      • Franklin, Tennessee, United States, 37067
        • Psychiatric Consultants, PC
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research, Inc.
      • Austin, Texas, United States, 78731
        • FutureSearch Trials
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Houston, Texas, United States, 77054
        • Ut Health-Houston
      • San Antonio, Texas, United States, 78229
        • San Antonio Psychiatric Research Center
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Utah
      • Clinton, Utah, United States, 84015
        • Ericksen Research and Development
      • Murray, Utah, United States, 84123
        • Radiant Research, Inc.
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research
      • Salt Lake City, Utah, United States, 84105
        • Psychiatric and Behavioral Solutions
    • Vermont
      • Woodstock, Vermont, United States, 05091
        • Neuropsychiatric Associates
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Seattle, Washington, United States, 98104
        • Summit Research Network (Seattle) Llc
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • Northbrooke Research Center
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation For Health Research & Education
      • Waukesha, Wisconsin, United States, 53188
        • Independent Psychiatric Consultants, Sc, Dba, Ipc Research

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:

  • 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

Exclusion 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 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1: Placebo + BMS-820836 (0.5 mg/day)
Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks
EXPERIMENTAL: Arm 2: Placebo + BMS-820836 (1 mg/day)
Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks
EXPERIMENTAL: Arm 3: Placebo + BMS-820836 (2 mg/day)
Drug: Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
Drug: BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term effects of BMS-820836 on blood pressure in patients with depression
Time Frame: Baseline through Week 54
Baseline through Week 54

Secondary Outcome Measures

Outcome Measure
Time Frame
• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
Time Frame: Baseline through Week 54
Baseline through Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

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

August 1, 2011

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

May 25, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (ESTIMATE)

May 27, 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

Other Study ID Numbers

  • CN162-010
  • 2010-024371-12 (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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