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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Placebo matching with BMS-820836
* Drug: BMS-820836
* Drug: Duloxetine
* Drug: Placebo matching with Duloxetine


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Duloxetine 30mg<br> | Drug: Duloxetine<br>* Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks<br>* Other names: Cymbalta;|
| Placebo Comparator: Arm 2: BMS-820836 placebo<br> | Drug: Placebo matching with BMS-820836<br>* Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks<br>|
| Experimental: Arm 3: BMS-820836 0.5-2.0 mg/day<br> | Drug: BMS-820836<br>* Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks<br>|
| Active Comparator: Arm 4: Duloxetine 30mg<br> | Drug: Duloxetine<br>* Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks<br>* Other names: Cymbalta;|
| Placebo Comparator: Arm 5: Duloxetine placebo<br> | Drug: Placebo matching with Duloxetine<br>* Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery Asberg Depression Rating Scale (MADRS) total score |  | End of phase B and End of phase C | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |