Trials / Completed
CompletedNCT02085135
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3 study designed to evaluate the safety and tolerability of two titration schedules for ALKS 5461.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 5461 | Sublingual tablet taken once daily |
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2014-09-01
- Completion
- 2014-09-01
- First posted
- 2014-03-12
- Last updated
- 2019-08-14
- Results posted
- 2019-03-27
Locations
9 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02085135. Inclusion in this directory is not an endorsement.