Trials / Completed
CompletedNCT02218008
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-5 Study)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 407 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of ALKS 5461.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 5461 | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
| DRUG | Placebo | Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant) |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-09-01
- Completion
- 2016-10-01
- First posted
- 2014-08-15
- Last updated
- 2019-08-14
- Results posted
- 2019-03-27
Locations
44 sites across 4 countries: United States, Canada, Germany, Puerto Rico
Source: ClinicalTrials.gov record NCT02218008. Inclusion in this directory is not an endorsement.