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NCT02158546 · ClinicalTrials.gov registry record · Phase 3
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 447
- Enrollment target
NCT02158546: Completed Phase 3 study, sponsored by Alkermes.
NCT02158546 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02158546, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 447 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy and safety of ALKS 5461.
Primary Outcome
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Interventions
- DRUG Placebo
- DRUG ALKS 5461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 447 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
What the finished NCT02158546 record still lists
NCT02158546 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02158546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02158546 about?
NCT02158546 is a clinical study titled "A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-3 Study". This study will evaluate the efficacy and safety of ALKS 5461.
What is the current status of trial NCT02158546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2014-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02158546?
The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT02158546?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02158546's enrollment target sits among peer trials
447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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