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NCT03610048 · ClinicalTrials.gov registry record · Phase 3
A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)
A Phase 3 study, sponsored by Alkermes.
- Terminated
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
NCT03610048: Clinical Trial Phase 3 study, sponsored by Alkermes.
NCT03610048 is a Phase 3 study that was terminated before completion, run by Alkermes. The registered enrollment target is 175 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03610048, a Phase 3 study, was terminated before completion, sponsored by Alkermes.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
Study Summary
This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
Primary Outcome
Number and percentage of subjects experiencing TEAEs
Interventions
- DRUG ALKS 5461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2018-08-09 |
| Est. Completion | 2020-05-01 |
| Phase | Phase 3 |
Why NCT03610048 stopped before completion
NCT03610048 is an interventional study that assigns participants to a tested intervention. The registered 175 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 (77% lower).
The record links to 0 conditions, and to 1 intervention - of which ALKS 5461 is the first listed.
NCT03610048 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03610048 about?
NCT03610048 is a clinical study titled "A Long Term Study of ALKS 5461 in the Treatment of Refractory Major Depressive Disorder (MDD)". This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
What is the current status of trial NCT03610048?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2018-08-09. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03610048?
The interventions under investigation include: ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT03610048?
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 NCT03610048's enrollment target sits among peer trials
175 1440th of 2000 higher than 559 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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