drugset / Trial / NCT01381107

ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD

NCT01381107

Phase 1/2 Completed 32 enrolled Alkermes, Inc.
RandomizedParallel-groupTriple-blind

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

Timeline

Start
2011-05
Primary completion
2011-07
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Subject ALKS 5461 Unknown Other