Depression Clinical Trial
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).
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).
Status | Completed |
Enrollment | 976 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Argentina | Local Institution | Caba | Buenos Aires |
Argentina | Local Institution | Caba | Buenos Aires |
Argentina | Local Institution | Cordoba | |
Argentina | Local Institution | Cordoba | |
Argentina | Local Institution | La Plata | Buenos Aires |
Argentina | Local Institution | Mendoza | |
Australia | Local Institution | Adelaide | South Australia |
Australia | Local Institution | Brisbane | Queensland |
Australia | Local Institution | Heidelberg | Victoria |
Australia | Local Institution | Nedlands | Western Australia |
Austria | Local Institution | Wien | |
Austria | Local Institution | Wien | |
Canada | Local Institution | Bathurst | New Brunswick |
Canada | Local Institution | Montreal | Quebec |
Canada | Local Institution | Montreal | Quebec |
Canada | Local Institution | Ottawa | Ontario |
Canada | Local Institution | Toronto | Ontario |
Canada | Local Institution | Vancouver | British Columbia |
France | Local Institution | Dole | |
France | Local Institution | Douai | |
France | Local Institution | Elancourt | |
France | Local Institution | Jonzac Cedex | |
France | Local Institution | Montpellier Cedex 5 | |
India | Local Institution | Ahmedabad | Gujarat |
India | Local Institution | Chennai | |
India | Local Institution | Lucknow | Uttar Pradesh |
India | Local Institution | Mumbai | Maharashtra |
India | Local Institution | Pune | Maharashtra |
India | Local Institution | Pune | |
India | Local Institution | Tirupati | Andhra Pradesh |
India | Local Institution | Varanasi | |
India | Local Institution | Visakhapatnam | Andhra Pradesh |
Italy | Local Institution | Pisa | |
Italy | Local Institution | Roma | |
Italy | Local Institution | Siena | |
Puerto Rico | Local Institution | Ponce | |
South Africa | Local Institution | Durban | Kwa Zulu Natal |
South Africa | Local Institution | Pretoria | Gauteng |
South Africa | Local Institution | Pretoria | Gauteng |
South Africa | Local Institution | Pretoria | Gauteng |
Spain | Local Institution | Barcelona | |
Spain | Local Institution | Barcelona | |
United Kingdom | Local Institution | Birmingham | West Midlands |
United Kingdom | Local Institution | Edgware | Middlesex |
United Kingdom | Local Institution | London | Greater London |
United States | Albuquerque Neuroscience, Inc. | Albuquerque | New Mexico |
United States | Emory University | Atlanta | Georgia |
United States | Future Search Trials | Austin | Texas |
United States | Northcoast Clinical Trials, Inc | Beachwood | Ohio |
United States | Mclean Hospital | Belmont | Massachusetts |
United States | Birmingham Psychiatry Pharmaceutical Studies, Inc. | Birmingham | Alabama |
United States | Meridien Research | Brooksville | Florida |
United States | Uptown Research Institute, Llc | Chicago | Illinois |
United States | Catalina Research Institute, Llc | Chino | California |
United States | Patient Priority Clinical Sites, Llc | Cincinnati | Ohio |
United States | Ericksen Research And Development | Clinton | Utah |
United States | Connecticut Clinical Research | Cromwell | Connecticut |
United States | Futuresearch Trials Of Dallas | Dallas | Texas |
United States | Western Affiliated Research Institute | Denver | Colorado |
United States | Insite Clinical Research | Desoto | Texas |
United States | Gulfcoast Clinical Research Center | Fort Myers | Florida |
United States | Comprehensive Clinical Development, Inc | Fresh Meadows | New York |
United States | Behavioral Research Specialists, Llc | Glendale | California |
United States | Neuroscience, Inc | Herndon | Virginia |
United States | Ben Taub General Hospital | Houston | Texas |
United States | Amit Vijapura | Jacksonville | Florida |
United States | Lincoln Research | Lincoln | Rhode Island |
United States | Arkansas Psychiatric Clinic Clinical Research Trials, P.A. | Little Rock | Arkansas |
United States | Suburban Research Associates | Media | Pennsylvania |
United States | Dean Foundation For Health Research & Education | Middleton | Wisconsin |
United States | Bioscience Research, Llc | Mount Kisco | New York |
United States | Clinical Methods Llc | Murray | Utah |
United States | Village Clinical Research, Inc. | New York | New York |
United States | Keystone Clinical Studies, Llc | Norristown | Pennsylvania |
United States | Pacific Clinical Research Medical Group | Orange | California |
United States | Ert | Pittsburgh | Pennsylvania |
United States | Neuropsychiatric Research Center Of Orange County | Pittsburgh | Pennsylvania |
United States | Northwest Clinical Research Center | Pittsburgh | Pennsylvania |
United States | Clinical Trials Technology, Inc | Prairie Village | Kansas |
United States | Anderson Clinical Research | Redlands | California |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Affiliated Research Institute | San Diego | California |
United States | Artemis Institute For Clinical Research | San Diego | California |
United States | Sharp Mesa Vista Hospital | San Diego | California |
United States | Summit Research Network (Seattle) Llc | Seattle | Washington |
United States | Ert | Shreveport | Louisiana |
United States | Stedman Clinical Trials | Tampa | Florida |
United States | Clinco | Terre Haute | Indiana |
United States | Neurology & Neuroscience Center Of Ohio | Toledo | Ohio |
United States | Bio Behavioral Health | Toms River | New Jersey |
United States | Janus Center For Psychiatric Research | West Palm Beach | Florida |
United States | Grayline Clinical Drug Trials | Wichita Falls | Texas |
United States | Neuropsychiatric Associates | Woodstock | Vermont |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Canada, France, India, Italy, Puerto Rico, South Africa, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score | Week 13 | No | |
Secondary | Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. | Week 13 | No |
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