At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 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, Randomized, Double-blind Study to Evaluate the Safety and Tolerability of Two Titration Schedules for ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder in Adults With an Inadequate Response to Antidepressant Therapy (the FORWARD-1 Study)
In Brief
A Phase 3 clinical trial evaluating ALKS 5461 for Major Depressive Disorder. Completed, enrolled 66 participants across 9 sites in 2 countries.
Detailed Summary
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2014
First PostedMar 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedMar 12, 2014
Enrollment StartFeb 1, 2014
Primary CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.3 years ago
Interventions
ALKS 5461drug
Sublingual tablet taken once daily