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NCT03188185 · ClinicalTrials.gov registry record · Phase 3
A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 3
- Development phase
- 278
- Enrollment target
NCT03188185: Completed Phase 3 study, sponsored by Alkermes.
NCT03188185 is a Phase 3 study that has completed, run by Alkermes. The registered enrollment target is 278 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03188185, a Phase 3 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 278 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
Primary Outcome
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of Major Depressive Disorder (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 ALKS 5461
- DRUG ALKS 5461 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 278 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2020-03-05 |
| Phase | Phase 3 |
What the finished NCT03188185 record still lists
NCT03188185 is an interventional study that assigns participants to a tested intervention. The registered 278 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 (64% lower).
The record links to 0 conditions, and to 2 interventions - of which ALKS 5461 is the first listed.
NCT03188185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03188185 about?
NCT03188185 is a clinical study titled "A Study of ALKS 5461 for Treatment Refractory Major Depressive Disorder (MDD)". This study will evaluate the efficacy, safety, and tolerability of adjunctive ALKS 5461 in adults who have treatment refractory MDD.
What is the current status of trial NCT03188185?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 278 participants. The study started on 2017-06-12. Estimated completion is 2020-03-05.
What interventions are being tested in trial NCT03188185?
The interventions under investigation include: ALKS 5461 (DRUG), ALKS 5461 Placebo (DRUG).
Who is sponsoring clinical trial NCT03188185?
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 NCT03188185's enrollment target sits among peer trials
278 1200th of 2000 higher than 799 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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