At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 407 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.
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
In Brief
A Phase 3 clinical trial evaluating ALKS 5461 and Placebo for Major Depressive Disorder. Completed, enrolled 407 participants across 44 sites in 4 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
CountriesCanada, Germany, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedAug 2014
Primary CompletionSep 2016
Study CompletionOct 2016
TodayJul 2026
First PostedAug 15, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 1, 2016
Study CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.9 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)