Depression Clinical Trial
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
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).
Status | Completed |
Enrollment | 889 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Local Institution | Edmonton | Alberta |
Canada | Local Institution | Montreal | Quebec |
Canada | Local Institution | Quebec | |
Canada | Local Institution | Toronto | Ontario |
Canada | Local Institution | Vancouver | British Columbia |
Finland | Local Institution | Helsinki | |
Finland | Local Institution | Helsinki | |
Finland | Local Institution | Jarvenpaa | |
Finland | Local Institution | Oulu | |
Finland | Local Institution | Seinajoki | |
Finland | Local Institution | Tampere | |
Finland | Local Institution | Turku | |
France | Local Institution | Dole | |
France | Local Institution | Douai | |
France | Local Institution | Elancourt | |
France | Local Institution | Limoges Cedex | |
France | Local Institution | Montpellier Cedex 5 | |
France | Local Institution | Nimes | |
France | Local Institution | Paris | |
South Africa | Local Institution | Bellville | Western Cape |
South Africa | Local Institution | Cape Town | Western Cape |
South Africa | Local Institution | Johannesburg | Gauteng |
South Africa | Local Institution | Pretoria | Gauteng |
South Africa | Local Institution | Somerset West | Western Cape |
South Africa | Local Institution | Vereeniging | Gauteng |
Sweden | Local Institution | Halmstad | |
Sweden | Local Institution | Kungens Kurva | |
Sweden | Local Institution | Lund | |
Sweden | Local Institution | Uppsala | |
United States | Lehigh Center For Clinical Research | Allentown | Pennsylvania |
United States | Pacific Clinical Research Medical Group | Arcadia | California |
United States | Atlanta Institute Of Medicine & Research | Atlanta | Georgia |
United States | Comprehensive Clinical Development, Inc. | Atlanta | Georgia |
United States | Community Clinical Research, Inc. | Austin | Texas |
United States | Northwest Clinical Research Center | Bellevue | Washington |
United States | SPRI Clinical Trials, LLC | Brooklyn | New York |
United States | Northbrooke Research Center | Brown Deer | Wisconsin |
United States | Neurobehavioral Research, Inc. | Cedarhurst | New York |
United States | Carolina Clinical Research Services | Columbia | South Carolina |
United States | University Of South Carolina School Of Medicine | Columbia | South Carolina |
United States | Midwest Clinical Research Center | Dayton | Ohio |
United States | Radiant Research, Inc. | Denver | Colorado |
United States | Pharmacology Research Institute | Encino | California |
United States | Psychiatric Consultants, Pc | Franklin | Tennessee |
United States | Collaborative Neuroscience Network, Inc. | Garden Grove | California |
United States | Red Oak Psychiatry Associates | Houston | Texas |
United States | Uthealth - Houston | Houston | Texas |
United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
United States | Alpine Clinic | Lafayette | Indiana |
United States | K & S Professional Research Services, Llc | Little Rock | Arkansas |
United States | Pharmacology Research Institute | Los Alamitos | California |
United States | Loyola University Health System | Maywood | Illinois |
United States | Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee |
United States | Dean Foundation For Health Research & Education | Middleton | Wisconsin |
United States | Radiant Research, Inc. | Murray | Utah |
United States | James G. Barbee, Md, Llc | New Orleans | Louisiana |
United States | Pharmacology Research Institute | Newport Beach | California |
United States | Comprehensive Psychiatric Care | Norwich | Connecticut |
United States | Ips Research Company | Oklahoma City | Oklahoma |
United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
United States | Compass Research, Llc | Orlando | Florida |
United States | Belmont Center For Comprehensive Treatment | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | Univ Of Penn | Philadelphia | Pennsylvania |
United States | University Of Pennsylvania | Philadelphia | Pennsylvania |
United States | University Of Pennsylvania | Philadephia | Pennsylvania |
United States | Oregon Center For Clinical Investigations, Inc. (Occi, Inc) | Portland | Oregon |
United States | Summit Research Network (Oregon) Inc | Portland | Oregon |
United States | Clinical Trials Technology, Inc | Prairie Village | Kansas |
United States | Richard H. Weisler, Md, Pa & Assoc. | Raleigh | North Carolina |
United States | Finger Lakes Clinical Research | Rochester | New York |
United States | Oregon Center For Clinical Investigations, Inc (Occi, Inc) | Salem | Oregon |
United States | Psychiatric And Behavioral Solutions | Salt Lake City | Utah |
United States | San Antonio Psychiatric Research Center | San Antonio | Texas |
United States | California Neuropsychopharmacology Clinical Research Inst. | San Diego | California |
United States | Pacific Research Network, Inc | San Diego | California |
United States | Summit Research Network (Seattle) Llc | Seattle | Washington |
United States | California Neuroscience Research Medical Group, Inc. | Sherman Oaks | California |
United States | Schuster Medical Research Institute | Sherman Oaks | California |
United States | Carman Research | Smyrna | Georgia |
United States | Comprehensive Clinical Development, Inc. | St Petersburg | Florida |
United States | Tulsa Clinical Research, Llc | Tulsa | Oklahoma |
United States | Pacific Clinical Research Medical Group | Upland | California |
United States | Independent Psychiatric Consultants, Sc, Dba, Ipc Research | Waukesha | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Canada, Finland, France, South Africa, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery Asberg Depression Rating Scale (MADRS) total score | End of phase B and End of phase C | No | |
Secondary | Change in Sheehan Disability Scale (SDS) Total score | End of Phase B and End of Phase C | No | |
Secondary | Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score | End of Phase B and End of Phase C | No |
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