Clinical trial NCT01369095: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-06-08
Enrollment: 976
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score
timeFrame: Week 13
Secondary outcomes:
measure: Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score.
timeFrame: Week 13
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Chino
country: United States
facility: Catalina Research Institute, Llc
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, Llc
state: California
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute For Clinical Research
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Cromwell
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Amit Vijapura
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center For Psychiatric Research
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute, Llc
state: Illinois
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: Shreveport
country: United States
facility: Ert
state: Louisiana
city: Belmont
country: United States
facility: Mclean Hospital
state: Massachusetts
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Fresh Meadows
country: United States
facility: Comprehensive Clinical Development, Inc
state: New York
city: Mount Kisco
country: United States
facility: Bioscience Research, Llc
state: New York
city: New York
country: United States
facility: Village Clinical Research, Inc.
state: New York
city: Beachwood
country: United States
facility: Northcoast Clinical Trials, Inc
state: Ohio
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites, Llc
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center Of Ohio
state: Ohio
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Norristown
country: United States
facility: Keystone Clinical Studies, Llc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Ert
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Neuropsychiatric Research Center Of Orange County
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Northwest Clinical Research Center
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Austin
country: United States
facility: Future Search Trials
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials Of Dallas
state: Texas
city: Desoto
country: United States
facility: Insite Clinical Research
state: Texas
city: Houston
country: United States
facility: Ben Taub General Hospital
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Clinton
country: United States
facility: Ericksen Research And Development
state: Utah
city: Murray
country: United States
facility: Clinical Methods Llc
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Herndon
country: United States
facility: Neuroscience, Inc
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Summit Research Network (Seattle) Llc
state: Washington
city: Middleton
country: United States
facility: Dean Foundation For Health Research & Education
state: Wisconsin
city: Caba
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Caba
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Mendoza
country: Argentina
facility: Local Institution
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Nedlands
country: Australia
facility: Local Institution
state: Western Australia
city: Wien
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Bathurst
country: Canada
facility: Local Institution
state: New Brunswick
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Dole
country: France
facility: Local Institution
city: Douai
country: France
facility: Local Institution
city: Elancourt
country: France
facility: Local Institution
city: Jonzac Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Tirupati
country: India
facility: Local Institution
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Local Institution
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Local Institution
state: Gujarat
city: Mumbai
country: India
facility: Local Institution
state: Maharashtra
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Lucknow
country: India
facility: Local Institution
state: Uttar Pradesh
city: Chennai
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Varanasi
country: India
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Edgware
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Birmingham
country: United Kingdom
facility: Local Institution
state: West Midlands
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: