At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 278 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 3b Efficacy and Safety Study of Adjunctive ALKS 5461 in Treatment Refractory Major Depressive Disorder
In Brief
A Phase 3 clinical trial evaluating ALKS 5461 and ALKS 5461 Placebo for Major Depressive Disorder. Completed, enrolled 278 participants across 35 sites in 3 countries.
Detailed Summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesAustralia, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
Enrollment StartJun 2017
First PostedJun 2017
Primary CompletionFeb 2020
Study CompletionMar 2020
TodayJul 2026
First PostedJun 15, 2017
Enrollment StartJun 12, 2017
Primary CompletionFeb 26, 2020
Study CompletionMar 5, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.0 years ago
Interventions
ALKS 5461drug
Samidorphan + buprenorphine, administered sublingually
ALKS 5461 Placebodrug
Placebo tablet, administered sublingually