NCT01381107

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ALKS 5461	Sublingual administration once daily for 7 consecutive days.
DRUG	Placebo	Sublingual administration once daily for 7 consecutive days.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-06-27
• Last updated: 2011-08-23

Locations

2 sites across 1 country: United States