Conditions: Major Depressive Disorder
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.

Detailed description:
The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using other scales and assessments.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ALKS 5461 intervention 2: Placebo
Intervention descriptions: intervention 1: Two active tablets, given daily intervention 2: Two placebo tablets, given daily

Protocol document: