Efficacy and Safety of Fixed Doses of BMS 820836 in the Treatment of Patients With Treatment Resistant Major Depression



Status:Completed
Conditions:Depression, Major Depression Disorder (MDD)
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:July 2011
End Date:May 2013

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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).

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).


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.
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