At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,485 enrolled
Drug / intervention
ALKS 5461drug
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 Multicenter Study of the Long-Term Safety and Tolerability of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults Who Have an Inadequate Response to Antidepressant Therapy (the FORWARD-2 Study)
In Brief
A Phase 3 clinical trial evaluating ALKS 5461 for Major Depressive Disorder. Completed, enrolled 1,485 participants across 158 sites in 8 countries.
Detailed Summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Bulgaria, Canada, Germany, Hungary, Poland, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartMay 2014
First PostedMay 2014
Primary CompletionNov 2017
TodayJul 2026
First PostedMay 19, 2014
Enrollment StartMay 1, 2014
Primary CompletionNov 20, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 12.1 years ago
Interventions
ALKS 5461drug
Sublingual tablet, taken daily