Back to resultsEfficacy and Safety of Flexibly Dosed 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
Placebo matching with BMS-820836
BMS-820836
Duloxetine
Placebo matching with Duloxetine
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
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).
Sites / Locations
- K & S Professional Research Services, Llc
- Pacific Clinical Research Medical Group
- Pharmacology Research Institute
- Collaborative Neuroscience Network, Inc.
- Pharmacology Research Institute
- Pharmacology Research Institute
- California Neuropsychopharmacology Clinical Research Inst.
- Pacific Research Network, Inc
- California Neuroscience Research Medical Group, Inc.
- Schuster Medical Research Institute
- Pacific Clinical Research Medical Group
- Radiant Research, Inc.
- Comprehensive Psychiatric Care
- Clinical Neuroscience Solutions, Inc.
- Clinical Neuroscience Solutions, Inc.
- Compass Research, Llc
- Comprehensive Clinical Development, Inc.
- Atlanta Institute Of Medicine & Research
- Comprehensive Clinical Development, Inc.
- Carman Research
- Loyola University Health System
- Alpine Clinic
- Clinical Trials Technology, Inc
- James G. Barbee, Md, Llc
- SPRI Clinical Trials, LLC
- Neurobehavioral Research, Inc.
- Finger Lakes Clinical Research
- Richard H. Weisler, Md, Pa & Assoc.
- Midwest Clinical Research Center
- Ips Research Company
- Tulsa Clinical Research, Llc
- Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
- Summit Research Network (Oregon) Inc
- Oregon Center For Clinical Investigations, Inc (Occi, Inc)
- Lehigh Center For Clinical Research
- Univ Of Penn
- University Of Pennsylvania
- Thomas Jefferson University
- Belmont Center For Comprehensive Treatment
- University Of Pennsylvania
- Carolina Clinical Research Services
- University Of South Carolina School Of Medicine
- Psychiatric Consultants, Pc
- Clinical Neuroscience Solutions, Inc.
- Community Clinical Research, Inc.
- Uthealth - Houston
- Red Oak Psychiatry Associates
- San Antonio Psychiatric Research Center
- Radiant Research, Inc.
- Psychiatric And Behavioral Solutions
- Northwest Clinical Research Center
- Summit Research Network (Seattle) Llc
- Northbrooke Research Center
- Dean Foundation For Health Research & Education
- Independent Psychiatric Consultants, Sc, Dba, Ipc Research
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Placebo Comparator
Experimental
Active Comparator
Placebo Comparator
Arm Label
Arm 1: Duloxetine 30mg
Arm 2: BMS-820836 placebo
Arm 3: BMS-820836 0.5-2.0 mg/day
Arm 4: Duloxetine 30mg
Arm 5: Duloxetine placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Secondary Outcome Measures
Change in Sheehan Disability Scale (SDS) Total score
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Full Information
NCT ID
NCT01309945
First Posted
February 15, 2011
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01309945
Brief Title
Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 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 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
ParticipantInvestigator
Allocation
Randomized
Enrollment
889 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Duloxetine 30mg
Arm Type
Active Comparator
Arm Title
Arm 2: BMS-820836 placebo
Arm Type
Placebo Comparator
Arm Title
Arm 3: BMS-820836 0.5-2.0 mg/day
Arm Type
Experimental
Arm Title
Arm 4: Duloxetine 30mg
Arm Type
Active Comparator
Arm Title
Arm 5: Duloxetine placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with BMS-820836
Intervention Description
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-820836
Intervention Description
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching with Duloxetine
Intervention Description
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
Primary Outcome Measure Information:
Title
Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Time Frame
End of phase B and End of phase C
Secondary Outcome Measure Information:
Title
Change in Sheehan Disability Scale (SDS) Total score
Time Frame
End of Phase B and End of Phase C
Title
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
Time Frame
End of Phase B and End of Phase C
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:
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).
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
K & S Professional Research Services, Llc
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72201
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Pharmacology Research Institute
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pharmacology Research Institute
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
California Neuropsychopharmacology Clinical Research Inst.
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
Pacific Research Network, Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Compass Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Comprehensive Clinical Development, Inc.
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Atlanta Institute Of Medicine & Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Comprehensive Clinical Development, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Loyola University Health System
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Alpine Clinic
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Clinical Trials Technology, Inc
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
James G. Barbee, Md, Llc
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
SPRI Clinical Trials, LLC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Finger Lakes Clinical Research
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Richard H. Weisler, Md, Pa & Assoc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Ips Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Tulsa Clinical Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Summit Research Network (Oregon) Inc
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc (Occi, Inc)
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Lehigh Center For Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Univ Of Penn
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Belmont Center For Comprehensive Treatment
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States
Facility Name
University Of Pennsylvania
City
Philadephia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Carolina Clinical Research Services
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
University Of South Carolina School Of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Psychiatric Consultants, Pc
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
Country
United States
Facility Name
Uthealth - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
Red Oak Psychiatry Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
San Antonio Psychiatric Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research, Inc.
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Psychiatric And Behavioral Solutions
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84105
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Summit Research Network (Seattle) Llc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northbrooke Research Center
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
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
Independent Psychiatric Consultants, Sc, Dba, Ipc Research
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 6W6
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5g 2n2
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4H 1R3
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Local Institution
City
Helsinki
ZIP/Postal Code
00260
Country
Finland
Facility Name
Local Institution
City
Jarvenpaa
ZIP/Postal Code
04400
Country
Finland
Facility Name
Local Institution
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Local Institution
City
Seinajoki
ZIP/Postal Code
60100
Country
Finland
Facility Name
Local Institution
City
Tampere
ZIP/Postal Code
33200
Country
Finland
Facility Name
Local Institution
City
Turku
ZIP/Postal Code
20100
Country
Finland
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
Limoges Cedex
ZIP/Postal Code
87025
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2195
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0183
Country
South Africa
Facility Name
Local Institution
City
Vereeniging
State/Province
Gauteng
ZIP/Postal Code
1939
Country
South Africa
Facility Name
Local Institution
City
Bellville
State/Province
Western Cape
ZIP/Postal Code
7535
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Local Institution
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
Facility Name
Local Institution
City
Halmstad
ZIP/Postal Code
302 48
Country
Sweden
Facility Name
Local Institution
City
Kungens Kurva
ZIP/Postal Code
141 75
Country
Sweden
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
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 Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
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