Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

September 23, 2015 updated by: Bristol-Myers Squibb

A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

889

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

      • Quebec, Canada, G3K 2P8
        • Local Institution
    • Alberta
      • Edmonton, Alberta, Canada, T6L 6W6
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada, H4H 1R3
        • Local Institution
      • 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
      • Dole, France, 39100
        • Local Institution
      • Douai, France, 59500
        • Local Institution
      • Elancourt, France, 78990
        • Local Institution
      • Limoges Cedex, France, 87025
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Institution
      • Nimes, France, 30900
        • Local Institution
      • Paris, France, 75012
        • Local Institution
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2195
        • Local Institution
      • Pretoria, Gauteng, South Africa, 0183
        • Local Institution
      • Vereeniging, Gauteng, South Africa, 1939
        • Local Institution
    • Western Cape
      • Bellville, Western Cape, South Africa, 7535
        • Local Institution
      • Cape Town, Western Cape, South Africa, 7530
        • Local Institution
      • Somerset West, Western Cape, South Africa, 7130
        • Local Institution
      • Halmstad, Sweden, 302 48
        • Local Institution
      • Kungens Kurva, Sweden, 141 75
        • Local Institution
      • Lund, Sweden, 222 22
        • Local Institution
      • Uppsala, Sweden, 751 85
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • K & S Professional Research Services, LLC
    • California
      • Arcadia, California, United States, 91007
        • Pacific Clinical Research Medical Group
      • Encino, California, United States, 91316
        • Pharmacology Research Institute
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • San Diego, California, United States, 92102
        • California Neuropsychopharmacology Clinical Research Inst.
      • 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, 80239
        • Radiant Research, Inc.
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, Inc.
      • St Petersburg, Florida, United States, 33716
        • Comprehensive Clinical Development, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Atlanta Institute of Medicine & Research
      • Atlanta, Georgia, United States, 30328
        • Comprehensive Clinical Development, Inc.
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Health System
    • Indiana
      • Lafayette, Indiana, United States, 47905
        • Alpine Clinic
    • Kansas
      • Prairie Village, Kansas, United States, 66206
        • Clinical Trials Technology, Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • James G. Barbee, Md, Llc
    • New York
      • Brooklyn, New York, United States, 11235
        • SPRI Clinical Trials, LLC
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • Rochester, New York, United States, 14618
        • Finger Lakes Clinical Research
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, Md, Pa & Assoc.
    • Ohio
      • Dayton, Ohio, United States, 45417
        • Midwest Clinical Research Center
    • 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
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19131
        • Belmont Center For Comprehensive Treatment
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ Of Penn
      • Philadephia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • University of South Carolina School of Medicine
      • 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.
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates
      • Houston, Texas, United States, 77054
        • Uthealth - Houston
      • San Antonio, Texas, United States, 78229
        • San Antonio Psychiatric Research Center
    • Utah
      • Murray, Utah, United States, 84123
        • Radiant Research, Inc.
      • Salt Lake City, Utah, United States, 84105
        • Psychiatric and Behavioral Solutions
    • Washington
      • Bellevue, Washington, United States, 98004
        • 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:

  • 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.

Exclusion Criteria:

  • 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 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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1: Duloxetine 30mg
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Names:
  • Cymbalta
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Names:
  • Cymbalta
Placebo Comparator: Arm 2: BMS-820836 placebo
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Active Comparator: Arm 4: Duloxetine 30mg
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Other Names:
  • Cymbalta
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Other Names:
  • Cymbalta
Placebo Comparator: Arm 5: Duloxetine placebo
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Time Frame: End of phase B and End of phase C
End of phase B and End of phase C

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Sheehan Disability Scale (SDS) Total score
Time Frame: End of Phase B and End of Phase C
End of Phase B and End of Phase C
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Time Frame: End of Phase B and End of Phase C
End of Phase B and End of Phase C

Collaborators and Investigators

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

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.

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

April 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 15, 2011

First Submitted That Met QC Criteria

March 4, 2011

First Posted (Estimate)

March 7, 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

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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