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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
789

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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