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

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369095
• Other study ID #: CN162-007
• Secondary ID: 2011-000778-71
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: September 23, 2015
• Start date: July 2011
• Est. completion date: May 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of PersonnesSouth Africa: Medicines Control CouncilSouth Africa: Department of HealthGermany: Federal Institute for Drugs and Medical DevicesAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: Federal Office for Safety in Health CareSpain: Spanish Agency of MedicinesArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Duloxetine
Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)
• Escitalopram
Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)
• BMS-820836 Placebo
Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
• BMS-820836
Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
• BMS-820836
Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
• BMS-820836
Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
• BMS-820836
Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Canada,  France,  India,  Italy,  Puerto Rico,  South Africa,  Spain,  United Kingdom, 

Outcome

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

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form