Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Depression Clinical Trial

Official title:

A Multicenter, Double-Blind, 58 Week Rollover Study to Assess the Safety and Tolerability of BMS-820836 in Patients With Treatment Resistant Major Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01361555
• Other study ID #: CN162-010
• Secondary ID: 2010-024371-12
• Status: Terminated
• Phase: Phase 2
• First received: May 25, 2011
• Last updated: September 23, 2015
• Start date: August 2011
• Est. completion date: October 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 BoardSweden: Medical Products AgencyFinland: Finnish Medicines AgencyCanada: 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 this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 789
• Est. completion date: October 2013
• Est. primary completion date: October 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 the minimum age will be 24 years of age)

• Patients randomized in parent study who complete CN162-006 and CN162-007 who consent to enter the rollover study.

• Patient not randomized in parent study that meet inadequate response criteria

Exclusion Criteria:

• Patients who represent a significant risk of committing suicide based on the clinical judgment of the investigator, history or routine psychiatric status exam.

• Patients with a Cardiovascular System Organ Class adverse event(s) occurring in parent study (CN162-006 or CN162-007), that in the investigators judgment is clinically significant and would impact safety of the subject in the current study [including but not limited to left bundle branch block, or prolonged QT interval corrected (QTc)].

• In addition, patients should be excluded if they have any laboratory test, vital sign, electrocardiogram (ECG) or clinical findings that in the investigator's judgment is clinically significantly abnormal and could impact the safety of the patient or the interpretation of study assessments in the current study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety 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:
• Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, Once daily, 54 weeks
• BMS-820836
Tablet, Oral, 0.5 mg, Once daily, 54 weeks
• BMS-820836
Tablet, Oral, 1.0 mg, Once daily, 54 weeks
• BMS-820836
Tablet, Oral, 2.0 mg, Once daily, 54 weeks

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
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	Jonzac
France	Local Institution	Limoges Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Paris
India	Local Institution	Ahmedabad	Gujarat
India	Local Institution	Chennai
India	Local Institution	Mumbai	Maharashtra
India	Local Institution	Pune	Maharashtra
India	Local Institution	Pune
India	Local Institution	Varanasi
India	Local Institution	Vishakapattanam
Italy	Local Institution	Pisa
Italy	Local Institution	Siena
Puerto Rico	Local Institution	Ponce
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
Spain	Local Institution	Arganda Del Rey
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Sweden	Local Institution	Halmstad
Sweden	Local Institution	Kungens Kurva
Sweden	Local Institution	Lund
Sweden	Local Institution	Uppsala
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
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	Emory University	Atlanta	Georgia
United States	Community Clinical Research, Inc.	Austin	Texas
United States	Futuresearch Trials	Austin	Texas
United States	Northcoast Clinical Trials, Inc	Beachwood	Ohio
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Mclean Hospital	Belmont	Massachusetts
United States	Birmingham Psychiatry Pharmaceutical Studies, Inc.	Birmingham	Alabama
United States	Spri Clinical Trials, Llc	Brooklyn	New York
United States	Meridien Research	Brooksville	Florida
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Carolinas Healthcare System	Charlotte	North Carolina
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	Carolina Clinical Research Services	Columbia	South Carolina
United States	Connecticut Clinical Research	Cromwell	Connecticut
United States	Futuresearch Trials Of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Pharmacology Research Institute	Encino	California
United States	Gulfcoast Clinical Research Center	Fort Myers	Florida
United States	Psychiatric Consultants, Pc	Franklin	Tennessee
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Behavioral Research Specialists, Llc	Glendale	California
United States	Baylor College Of Medicine	Houston	Texas
United States	Red Oak Psychiatry Associates, Pa	Houston	Texas
United States	Ut Health-Houston	Houston	Texas
United States	Amit Vijapura	Jacksonville	Florida
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Comprehensive Clinical Development, Inc	Jamaica	New York
United States	Alpine Clinic	Lafayette	Indiana
United States	Lincoln Research	Lincoln	Rhode Island
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	K & S Professional Research Services, Llc	Little Rock	Arkansas
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Suburban Research Associates	Media	Pennsylvania
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	Village Clinical Research, Inc.	New York	New York
United States	Pharmacology Research Institute	Newport Beach	California
United States	Keystone Clinical Studies, Llc	Norristown	Pennsylvania
United States	Ips Research Company	Oklahoma City	Oklahoma
United States	Neuropsychiatric Research Center Of Orange County	Orange	California
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research, Llc	Orlando	Florida
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	Philadelphia	Pennsylvania
United States	Bioscience Research, Llc	Pittsburgh	Pennsylvania
United States	Comprehensive Psychiatric Care	Pittsburgh	Pennsylvania
United States	Insite Clinical Research	Pittsburgh	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	Anderson Clinical Research	Redlands	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Comprehensive Clinical Development, Inc.	Saint Petersburg	Florida
United States	Oregon Center For Clinical Investigations, Inc (Occi, Inc)	Salem	Oregon
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Psychiatric And Behavioral Solutions	Salt Lake City	Utah
United States	San Antonio Psychiatric Research Center	San Antonio	Texas
United States	Affiliated Research Institute	San Diego	California
United States	Artemis Institute For Clinical Research	San Diego	California
United States	California Neuropsychopharmacology Clinical	San Diego	California
United States	Pacific Research Network	San Diego	California
United States	Sharp Mesa Vista Hospital	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	J. Gary Booker, Md, Apmc	Shreveport	Louisiana
United States	Carman Research	Smyrna	Georgia
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	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
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,  Finland,  France,  India,  Italy,  Puerto Rico,  South Africa,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term effects of BMS-820836 on blood pressure in patients with depression		Baseline through Week 54	No
Secondary	• Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs		Baseline through Week 54	Yes

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