At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 385 enrolled
Drug / intervention
High Dose ALKS 5461 +2 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-4 Study)
In Brief
A Phase 3 clinical trial evaluating High Dose ALKS 5461, Low Dose ALKS 5461, and 1 other intervention for Major Depressive Disorder. Completed, enrolled 385 participants across 49 sites in 3 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
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedJun 2014
Primary CompletionDec 2015
TodayJul 2026
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
High Dose ALKS 5461drug
Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Low Dose 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)