Trials / Completed
CompletedNCT02141399
A Long-Term Safety Study of ALKS 5461
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,485 (actual)
- Sponsor
- Alkermes, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a 52-week open-label study to evaluate the safety and tolerability of ALKS 5461.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALKS 5461 | Sublingual tablet, taken daily |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2017-11-20
- Completion
- 2017-11-20
- First posted
- 2014-05-19
- Last updated
- 2018-12-14
- Results posted
- 2018-12-14
Locations
158 sites across 8 countries: United States, Australia, Bulgaria, Canada, Germany, Hungary, Poland, Puerto Rico
Source: ClinicalTrials.gov record NCT02141399. Inclusion in this directory is not an endorsement.