Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression Alkermes ALKS 5461 Samidorphan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 385
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of ALKS 5461.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: High Dose ALKS 5461 intervention 2: Low Dose ALKS 5461 intervention 3: Placebo
Intervention descriptions: intervention 1: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 2: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) intervention 3: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Protocol document: