Clinical trial NCT01361555: Long-term Safety and Tolerability of BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-05-27
Enrollment: 789
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 this study it to evaluate the long-term safety and tolerability of BMS-820836 in patients with depression.


Eligibility criteria: 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.

Primary outcomes:
measure: Long-term effects of BMS-820836 on blood pressure in patients with depression
timeFrame: Baseline through Week 54
Secondary outcomes:
measure: • Adverse Events (AEs), Serious Adverse Events, and Discontinuations Due to AEs
timeFrame: Baseline through Week 54
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Psychiatry Pharmaceutical Studies, Inc.
state: Alabama
city: Little Rock
country: United States
facility: K & S Professional Research Services, Llc
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Psychiatric Clinic Clinical Research Trials, P.A.
state: Arkansas
city: Arcadia
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Chino
country: United States
facility: Catalina Research Institute, Llc
state: California
city: Encino
country: United States
facility: Pharmacology Research Institute
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Glendale
country: United States
facility: Behavioral Research Specialists, Llc
state: California
city: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Orange
country: United States
facility: Neuropsychiatric Research Center Of Orange County
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: California Neuropsychopharmacology Clinical
state: California
city: San Diego
country: United States
facility: Pacific Research Network
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: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc.
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Denver
country: United States
facility: Western Affiliated Research Institute
state: Colorado
city: Denver
country: United States
facility: Radiant Research, Inc.
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: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Compass Research, Llc
state: Florida
city: Saint Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc.
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: Atlanta
country: United States
facility: Atlanta Institute Of Medicine & Research
state: Georgia
city: Atlanta
country: United States
facility: Comprehensive Clinical Development, Inc
state: Georgia
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Lafayette
country: United States
facility: Alpine Clinic
state: Indiana
city: Terre Haute
country: United States
facility: Clinco
state: Indiana
city: Prairie Village
country: United States
facility: Clinical Trials Technology, Inc
state: Kansas
city: New Orleans
country: United States
facility: James G. Barbee, Md, Llc
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker, Md, Apmc
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: Brooklyn
country: United States
facility: Spri Clinical Trials, Llc
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Jamaica
country: United States
facility: Comprehensive Clinical Development, Inc
state: New York
city: New York
country: United States
facility: Village Clinical Research, Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler, Md, Pa & Assoc.
state: North Carolina
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: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Toledo
country: United States
facility: Neurology & Neuroscience Center Of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Ips Research Company
state: Oklahoma
city: Tulsa
country: United States
facility: Tulsa Clinical Research, Llc
state: Oklahoma
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
state: Oregon
city: Portland
country: United States
facility: Summit Research Network (Oregon) Inc
state: Oregon
city: Salem
country: United States
facility: Oregon Center For Clinical Investigations, Inc (Occi, Inc)
state: Oregon
city: Allentown
country: United States
facility: Lehigh Center For Clinical Research
state: Pennsylvania
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Norristown
country: United States
facility: Keystone Clinical Studies, Llc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Univ Of Penn
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Comprehensive Psychiatric Care
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Bioscience Research, Llc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Insite Clinical Research
state: Pennsylvania
city: Lincoln
country: United States
facility: Lincoln Research
state: Rhode Island
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Franklin
country: United States
facility: Psychiatric Consultants, Pc
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Futuresearch Trials
state: Texas
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials Of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: Ut Health-Houston
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, Pa
state: Texas
city: San Antonio
country: United States
facility: San Antonio Psychiatric Research Center
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: Radiant Research, Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Psychiatric And Behavioral Solutions
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Woodstock
country: United States
facility: Neuropsychiatric Associates
state: Vermont
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle) Llc
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
city: Middleton
country: United States
facility: Dean Foundation For Health Research & Education
state: Wisconsin
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants, Sc, Dba, Ipc Research
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: Helsinki
country: Finland
facility: Local Institution
city: Helsinki
country: Finland
facility: Local Institution
city: Jarvenpaa
country: Finland
facility: Local Institution
city: Oulu
country: Finland
facility: Local Institution
city: Seinajoki
country: Finland
facility: Local Institution
city: Tampere
country: Finland
facility: Local Institution
city: Turku
country: Finland
facility: Local Institution
city: Dole
country: France
facility: Local Institution
city: Douai
country: France
facility: Local Institution
city: Elancourt
country: France
facility: Local Institution
city: Jonzac
country: France
facility: Local Institution
city: Limoges Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
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: Chennai
country: India
facility: Local Institution
city: Pune
country: India
facility: Local Institution
city: Varanasi
country: India
facility: Local Institution
city: Vishakapattanam
country: India
facility: Local Institution
city: Pisa
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Ponce
country: Puerto Rico
facility: Local Institution
city: Johannesburg
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: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Arganda Del Rey
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Halmstad
country: Sweden
facility: Local Institution
city: Kungens Kurva
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: