CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 142 enrolled
Drug / intervention
ALKS 5461 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01500200
NCT01500200Phase 2Completed
CompareCT.gov

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

Alkermes, Inc.·interventional·Posted Dec 28, 2011·Updated May 21, 2019

In Brief

A Phase 2 clinical trial evaluating ALKS 5461 and Placebo for Major Depressive Disorder. Completed, enrolled 142 participants across 27 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartDec 1, 2011
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.5 years ago

Interventions

ALKS 5461drug

Two active tablets, given daily

Placebodrug

Two placebo tablets, given daily