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

Bristol-Myers Squibb48 sites in 2 countries889 target enrollmentApril 2011

ConditionsDepression

InterventionsDuloxetine Placebo matching with BMS-820836 BMS-820836 Placebo matching with Duloxetine

DrugsDuloxetine Placebo matching with BMS-820836 BMS-820836 Placebo matching with Duloxetine

Overview

Phase: Phase 2
Intervention: Duloxetine
Conditions: Depression
Sponsor: Bristol-Myers Squibb
Enrollment: 889
Locations: 48
Primary Endpoint: Change in Montgomery Asberg Depression Rating Scale (MADRS) total score
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 2011

End Date

January 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

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).

Arms & Interventions

Arm 1: Duloxetine 30mg

Intervention: Duloxetine

Arm 2: BMS-820836 placebo

Intervention: Placebo matching with BMS-820836

Arm 3: BMS-820836 0.5-2.0 mg/day

Intervention: BMS-820836

Arm 4: Duloxetine 30mg

Intervention: Duloxetine

Arm 5: Duloxetine placebo

Intervention: Placebo matching with Duloxetine

Outcomes

Primary Outcomes

Change in Montgomery Asberg Depression Rating Scale (MADRS) total score

Time Frame: End of phase B and End of phase C

Secondary Outcomes

Change in Sheehan Disability Scale (SDS) Total score(End of Phase B and End of Phase C)
Change in the Montgomery Asberg Depression Rating Scale (MADRS) anhedonia factor score(End of Phase B and End of Phase C)