Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression

Depression Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Active-Controlled Study of the Efficacy and Safety of Flexibly-Dosed BMS-820836 in Patients With Treatment Resistant Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309945
• Other study ID #: CN162-006
• Secondary ID: 2010-022841-93
• Status: Completed
• Phase: Phase 2
• First received: February 15, 2011
• Last updated: September 23, 2015
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFinland: Finnish Medicines AgencyCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)South Africa: Medicines Control CouncilSouth Africa: Department of HealthUnited States: Food and Drug Administration
• 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 in the treatment of patients with treatment resistant depression (TRD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 889
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

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 at an adequate dose and for an adequate duration in their current episode unless in the judgment of the investigator, the patient could benefit from the treatment with this medication.

• Patients whose only inadequate response to an antidepressant in the current Major Depressive Episode (MDE) is to an Serotonin norepinephrine reuptake inhibitors (SNRI) (duloxetine, venlafaxine, desvenlafaxine or milnacipran).

Study Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Drug:
• Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
• Placebo matching with BMS-820836
Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
• BMS-820836
Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
• Duloxetine
Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
• Placebo matching with Duloxetine
Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks

Locations

Country	Name	City	State
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
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	Limoges Cedex
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nimes
France	Local Institution	Paris
South Africa	Local Institution	Bellville	Western Cape
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Johannesburg	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Somerset West	Western Cape
South Africa	Local Institution	Vereeniging	Gauteng
Sweden	Local Institution	Halmstad
Sweden	Local Institution	Kungens Kurva
Sweden	Local Institution	Lund
Sweden	Local Institution	Uppsala
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	Community Clinical Research, Inc.	Austin	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	SPRI Clinical Trials, LLC	Brooklyn	New York
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Carolina Clinical Research Services	Columbia	South Carolina
United States	University Of South Carolina School Of Medicine	Columbia	South Carolina
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Pharmacology Research Institute	Encino	California
United States	Psychiatric Consultants, Pc	Franklin	Tennessee
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Red Oak Psychiatry Associates	Houston	Texas
United States	Uthealth - Houston	Houston	Texas
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alpine Clinic	Lafayette	Indiana
United States	K & S Professional Research Services, Llc	Little Rock	Arkansas
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Loyola University Health System	Maywood	Illinois
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	Pharmacology Research Institute	Newport Beach	California
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Ips Research Company	Oklahoma City	Oklahoma
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Compass Research, Llc	Orlando	Florida
United States	Belmont Center For Comprehensive Treatment	Philadelphia	Pennsylvania
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	Philadephia	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	Finger Lakes Clinical Research	Rochester	New York
United States	Oregon Center For Clinical Investigations, Inc (Occi, Inc)	Salem	Oregon
United States	Psychiatric And Behavioral Solutions	Salt Lake City	Utah
United States	San Antonio Psychiatric Research Center	San Antonio	Texas
United States	California Neuropsychopharmacology Clinical Research Inst.	San Diego	California
United States	Pacific Research Network, Inc	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	Carman Research	Smyrna	Georgia
United States	Comprehensive Clinical Development, Inc.	St Petersburg	Florida
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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada,  Finland,  France,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Montgomery Asberg Depression Rating Scale (MADRS) total score		End of phase B and End of phase C	No
Secondary	Change in Sheehan Disability Scale (SDS) Total score		End of Phase B and End of Phase C	No
Secondary	Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score		End of Phase B and End of Phase C	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