Clinical trial NCT01309945: Efficacy and Safety of Flexibly Dosed BMS-820836 in the Treatment of Patients With Treatment Resistant Major Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 889
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 in the treatment of patients with treatment resistant depression (TRD).


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
timeFrame: End of phase B and End of phase C
Secondary outcomes:
measure: Change in Sheehan Disability Scale (SDS) Total score
timeFrame: End of Phase B and End of Phase C
measure: Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score
timeFrame: End of Phase B and End of Phase C
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K & S Professional Research Services, Llc
state: Arkansas
city: Arcadia
country: United States
facility: Pacific Clinical Research Medical Group
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: Los Alamitos
country: United States
facility: Pharmacology Research Institute
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Inst.
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
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: Radiant Research, Inc.
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
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: St Petersburg
country: United States
facility: Comprehensive Clinical Development, Inc.
state: Florida
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 Health System
state: Illinois
city: Lafayette
country: United States
facility: Alpine Clinic
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: 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: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Raleigh
country: United States
facility: Richard H. Weisler, Md, Pa & Assoc.
state: North Carolina
city: Dayton
country: United States
facility: Midwest Clinical Research Center
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: 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: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Belmont Center For Comprehensive Treatment
state: Pennsylvania
city: Philadephia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Columbia
country: United States
facility: Carolina Clinical Research Services
state: South Carolina
city: Columbia
country: United States
facility: University Of South Carolina School Of Medicine
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: Community Clinical Research, Inc.
state: Texas
city: Houston
country: United States
facility: Uthealth - Houston
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates
state: Texas
city: San Antonio
country: United States
facility: San Antonio Psychiatric Research Center
state: Texas
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: 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: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
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: Limoges Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Nimes
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Vereeniging
country: South Africa
facility: Local Institution
state: Gauteng
city: Bellville
country: South Africa
facility: Local Institution
state: Western Cape
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Somerset West
country: South Africa
facility: Local Institution
state: Western Cape
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: