NCT01500200

A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ALKS 5461	Two active tablets, given daily
DRUG	Placebo	Two placebo tablets, given daily

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2011-12-28
• Last updated: 2019-05-21
• Results posted: 2019-05-21

Locations

27 sites across 1 country: United States