Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression

A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

The purpose of the study is to evaluate the efficacy of study drug (BMS-820836) as compared with continued Duloxetine/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Duloxetine; Drug: Escitalopram; Drug: BMS-820836 Placebo; Drug: BMS-820836; Drug: BMS-820836; Drug: BMS-820836; Drug: BMS-820836

• Study Type: Interventional
• Enrollment (Actual): 976
• Phase: Phase 2

Contacts and Locations

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
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2L4
      • Local Institution
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
      • Local Institution
  • Ontario
    • Ottawa, Ontario, Canada, K1Z 7K4
      • Local Institution
    • Toronto, Ontario, Canada, M4W 2N4
      • Local Institution
  • Quebec
    • Montreal, Quebec, Canada, H2R 1V6
      • Local Institution
    • Montreal, Quebec, Canada, H1N 3V2
      • Local Institution
• France
  • Dole, France, 39100
    • Local Institution
  • Douai, France, 59500
    • Local Institution
  • Elancourt, France, 78990
    • Local Institution
  • Jonzac Cedex, France, 175003
    • Local Institution
  • Montpellier Cedex 5, France, 34295
    • Local Institution
• India
  • Chennai, India, 600116
    • Local Institution
  • Pune, India, 411030
    • Local Institution
  • Varanasi, India, 211 005
    • Local Institution
  • Andhra Pradesh
    • Tirupati, Andhra Pradesh, India, 517 507
      • Local Institution
    • Visakhapatnam, Andhra Pradesh, 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
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226006
      • Local Institution
• Italy
  • Pisa, Italy, 56126
    • Local Institution
  • Roma, Italy, 00168
    • Local Institution
  • Siena, Italy, 53100
    • Local Institution
• Puerto Rico
  • Ponce, Puerto Rico, 00731
    • Local Institution
• South Africa
  • Gauteng
    • 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
• Spain
  • Barcelona, Spain, 08003
    • Local Institution
  • Barcelona, Spain, 08025
    • Local Institution
• United Kingdom
  • Greater London
    • London, Greater London, United Kingdom, W6 8RP
      • Local Institution
  • Middlesex
    • Edgware, Middlesex, United Kingdom, HA8 0AD
      • Local Institution
  • West Midlands
    • Birmingham, West Midlands, United Kingdom, B23 6DW
      • 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.
  • California
    • Chino, California, United States, 91710
      • Catalina Research Institute, LLC
    • Glendale, California, United States, 91206
      • Behavioral Research Specialists, LLC
    • Orange, California, United States, 92868
      • Pacific Clinical Research Medical Group
    • Redlands, California, United States, 92374
      • Anderson Clinical Research
    • 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
  • Colorado
    • Denver, Colorado, United States, 80209
      • Western Affiliated Research Institute
  • 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
      • Amit Vijapura
    • 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, 30306
      • Emory University
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Uptown Research Institute, LLC
  • Indiana
    • Terre Haute, Indiana, United States, 47802
      • Clinco
  • Kansas
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology, Inc
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
      • Ert
  • 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
    • Fresh Meadows, New York, United States, 11366
      • Comprehensive Clinical Development, Inc
    • Mount Kisco, New York, United States, 10549
      • Bioscience Research, LLC
    • New York, New York, United States, 10003
      • Village Clinical Research, Inc.
  • Ohio
    • Beachwood, Ohio, United States, 44122
      • Northcoast Clinical Trials, Inc
    • Cincinnati, Ohio, United States, 45215
      • Patient Priority Clinical Sites, LLC
    • Toledo, Ohio, United States, 43623
      • Neurology & Neuroscience Center Of Ohio
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Suburban Research Associates
    • Norristown, Pennsylvania, United States, 19403
      • Keystone Clinical Studies, LLC
    • Pittsburgh, Pennsylvania, United States, 15219
      • Ert
    • Pittsburgh, Pennsylvania, United States, 15219
      • Neuropsychiatric Research Center of Orange County
    • Pittsburgh, Pennsylvania, United States, 15219
      • Northwest Clinical Research Center
  • Rhode Island
    • Lincoln, Rhode Island, United States, 02865
      • Lincoln Research
  • Texas
    • Austin, Texas, United States, 78731
      • Future Search Trials
    • Dallas, Texas, United States, 75231
      • FutureSearch Trials of Dallas
    • Desoto, Texas, United States, 75115
      • InSite Clinical Research
    • Houston, Texas, United States, 77030
      • Ben Taub General Hospital
    • Wichita Falls, Texas, United States, 76309
      • Grayline Clinical Drug Trials
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research and Development
    • Murray, Utah, United States, 84107
      • Clinical Methods Llc
  • Vermont
    • Woodstock, Vermont, United States, 05091
      • Neuropsychiatric Associates
  • Virginia
    • Herndon, Virginia, United States, 20170
      • Neuroscience, Inc
    • Richmond, Virginia, United States, 23219
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • Summit Research Network (Seattle) Llc
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Dean Foundation For Health Research & Education

Participation Criteria

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 minimum age will be 24 years of age)
• 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 and Baseline.

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 and Escitalopram at an adequate dose and for an adequate duration in their current episode.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo	Drug: Duloxetine; Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D); Other Names: Cymbalta; Drug: Escitalopram; Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D); Other Names: Lexapro; Drug: BMS-820836 Placebo; Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Experimental: Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo; Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C); Drug: BMS-820836; Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo; Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C); Drug: BMS-820836; Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo; Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C); Drug: BMS-820836; Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Experimental: Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo	Drug: BMS-820836 Placebo; Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C); Drug: BMS-820836; Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C); Drug: BMS-820836; Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score	Week 13

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.	Week 13

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: June 7, 2011
• First Submitted That Met QC Criteria: June 7, 2011
• First Posted (Estimate): June 8, 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: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride; Citalopram
• Other Study ID Numbers: CN162-007; 2011-000778-71 (EudraCT Number)