CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 447 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/NCT02158546
NCT02158546Phase 3Completed
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A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-3 Study)

Alkermes, Inc.·interventional·Posted Jun 9, 2014·Updated Jun 25, 2019

In Brief

A Phase 3 clinical trial evaluating ALKS 5461 and Placebo for Major Depressive Disorder. Completed, enrolled 447 participants across 58 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesBulgaria, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 9, 2014
Enrollment StartMay 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.1 years ago

Interventions

ALKS 5461drug

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)

Placebodrug

Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)