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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Duloxetine
Escitalopram
BMS-820836 Placebo
BMS-820836
BMS-820836
BMS-820836
BMS-820836
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Birmingham Psychiatry Pharmaceutical Studies, Inc.
  • Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
  • Catalina Research Institute, Llc
  • Behavioral Research Specialists, Llc
  • Pacific Clinical Research Medical Group
  • Anderson Clinical Research
  • Affiliated Research Institute
  • Artemis Institute For Clinical Research
  • Sharp Mesa Vista Hospital
  • Western Affiliated Research Institute
  • Connecticut Clinical Research
  • Meridien Research
  • Gulfcoast Clinical Research Center
  • Amit Vijapura
  • Stedman Clinical Trials
  • Janus Center For Psychiatric Research
  • Emory University
  • Uptown Research Institute, Llc
  • Clinco
  • Clinical Trials Technology, Inc
  • Ert
  • Mclean Hospital
  • Bio Behavioral Health
  • Albuquerque Neuroscience, Inc.
  • Comprehensive Clinical Development, Inc
  • Bioscience Research, Llc
  • Village Clinical Research, Inc.
  • Northcoast Clinical Trials, Inc
  • Patient Priority Clinical Sites, Llc
  • Neurology & Neuroscience Center Of Ohio
  • Suburban Research Associates
  • Keystone Clinical Studies, Llc
  • Ert
  • Neuropsychiatric Research Center Of Orange County
  • Northwest Clinical Research Center
  • Lincoln Research
  • Future Search Trials
  • Futuresearch Trials Of Dallas
  • Insite Clinical Research
  • Ben Taub General Hospital
  • Grayline Clinical Drug Trials
  • Ericksen Research And Development
  • Clinical Methods Llc
  • Neuropsychiatric Associates
  • Neuroscience, Inc
  • Virginia Commonwealth University
  • Summit Research Network (Seattle) Llc
  • Dean Foundation For Health Research & Education
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo

Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo

Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo

Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo

Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score

Secondary Outcome Measures

Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.

Full Information

First Posted
June 7, 2011
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01369095
Brief Title
Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression
Official Title
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).
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
976 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo
Arm Type
Active Comparator
Arm Title
Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo
Arm Type
Experimental
Arm Title
Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo
Arm Type
Experimental
Arm Title
Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo
Arm Type
Experimental
Arm Title
Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro
Intervention Description
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)
Intervention Type
Drug
Intervention Name(s)
BMS-820836 Placebo
Intervention Description
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
Intervention Type
Drug
Intervention Name(s)
BMS-820836
Intervention Description
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
Intervention Type
Drug
Intervention Name(s)
BMS-820836
Intervention Description
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
Intervention Type
Drug
Intervention Name(s)
BMS-820836
Intervention Description
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
Intervention Type
Drug
Intervention Name(s)
BMS-820836
Intervention Description
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
Primary Outcome Measure Information:
Title
Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
Time Frame
Week 13
Secondary Outcome Measure Information:
Title
Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
Time Frame
Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Psychiatry Pharmaceutical Studies, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35226
Country
United States
Facility Name
Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72223
Country
United States
Facility Name
Catalina Research Institute, Llc
City
Chino
State/Province
California
ZIP/Postal Code
91710
Country
United States
Facility Name
Behavioral Research Specialists, Llc
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Anderson Clinical Research
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Artemis Institute For Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Mesa Vista Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Connecticut Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Gulfcoast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Amit Vijapura
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center For Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Uptown Research Institute, Llc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Clinco
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47802
Country
United States
Facility Name
Clinical Trials Technology, Inc
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Ert
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Mclean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Comprehensive Clinical Development, Inc
City
Fresh Meadows
State/Province
New York
ZIP/Postal Code
11366
Country
United States
Facility Name
Bioscience Research, Llc
City
Mount Kisco
State/Province
New York
ZIP/Postal Code
10549
Country
United States
Facility Name
Village Clinical Research, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Northcoast Clinical Trials, Inc
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Patient Priority Clinical Sites, Llc
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Neurology & Neuroscience Center Of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Keystone Clinical Studies, Llc
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States
Facility Name
Ert
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Neuropsychiatric Research Center Of Orange County
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Northwest Clinical Research Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Lincoln Research
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Future Search Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Futuresearch Trials Of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Insite Clinical Research
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Ericksen Research And Development
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Clinical Methods Llc
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Neuropsychiatric Associates
City
Woodstock
State/Province
Vermont
ZIP/Postal Code
05091
Country
United States
Facility Name
Neuroscience, Inc
City
Herndon
State/Province
Virginia
ZIP/Postal Code
20170
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Summit Research Network (Seattle) Llc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Dean Foundation For Health Research & Education
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Local Institution
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1405
Country
Argentina
Facility Name
Local Institution
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5003
Country
Argentina
Facility Name
Local Institution
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5112
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1010
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2L4
Country
Canada
Facility Name
Local Institution
City
Bathurst
State/Province
New Brunswick
ZIP/Postal Code
E2A 4X7
Country
Canada
Facility Name
Local Institution
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 7K4
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4W 2N4
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2R 1V6
Country
Canada
Facility Name
Local Institution
City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
Local Institution
City
Douai
ZIP/Postal Code
59500
Country
France
Facility Name
Local Institution
City
Elancourt
ZIP/Postal Code
78990
Country
France
Facility Name
Local Institution
City
Jonzac Cedex
ZIP/Postal Code
175003
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Tirupati
State/Province
Andhra Pradesh
ZIP/Postal Code
517 507
Country
India
Facility Name
Local Institution
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530002
Country
India
Facility Name
Local Institution
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 006
Country
India
Facility Name
Local Institution
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Local Institution
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Local Institution
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226006
Country
India
Facility Name
Local Institution
City
Chennai
ZIP/Postal Code
600116
Country
India
Facility Name
Local Institution
City
Pune
ZIP/Postal Code
411030
Country
India
Facility Name
Local Institution
City
Varanasi
ZIP/Postal Code
211 005
Country
India
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0181
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0187
Country
South Africa
Facility Name
Local Institution
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
3630
Country
South Africa
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
W6 8RP
Country
United Kingdom
Facility Name
Local Institution
City
Edgware
State/Province
Middlesex
ZIP/Postal Code
HA8 0AD
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B23 6DW
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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