Efficacy and Safety of Fixed Doses of 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/Escitalopram in the treatment of patients with treatment resistant depression (TRD).

Official Title
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A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD).

Conditions
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Depression

Intervention / Treatment
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* Drug: Duloxetine
* Drug: Escitalopram
* Drug: BMS-820836 Placebo
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836
* Drug: BMS-820836


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women of age 18-65 years (Argentina minimum age will be 24 years of age) 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 and Baseline. 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 and Escitalopram at an adequate dose and for an adequate duration in their current episode.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Duloxetine / Escitalopram + BMS-820836 placebo<br> | Drug: Duloxetine<br>* Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)<br>* Other names: Cymbalta;Drug: Escitalopram<br>* Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)<br>* Other names: Lexapro;Drug: BMS-820836 Placebo<br>* Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)<br>|
| Experimental: Arm 2: BMS-820836 (0.25 mg) + BMS-820836 placebo<br> | Drug: BMS-820836 Placebo<br>* Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)<br>Drug: BMS-820836<br>* Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)<br>|
| Experimental: Arm 3: BMS-820836 (0.50 mg) + BMS-820836 placebo<br> | Drug: BMS-820836 Placebo<br>* Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)<br>Drug: BMS-820836<br>* Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)<br>|
| Experimental: Arm 4: BMS-820836 (1.0 mg) + BMS-820836 placebo<br> | Drug: BMS-820836 Placebo<br>* Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)<br>Drug: BMS-820836<br>* Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)<br>|
| Experimental: Arm 5: BMS-820836 (2.0 mg) + BMS-820836 placebo<br> | Drug: BMS-820836 Placebo<br>* Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)<br>Drug: BMS-820836<br>* Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in the Montgomery Asberg Depression Rating Scale (MADRS) total score |  | Week 13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to endpoint in mean Sheehan Disability Scale (SDS) score. |  | Week 13 |