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NCT01381107 · ClinicalTrials.gov registry record · Phase 1
ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
A Phase 1 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT01381107: Completed Phase 1 study, sponsored by Alkermes.
NCT01381107 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01381107, a Phase 1 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially responding to current treatment with a stable dose of a serotonin-selective reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).
Primary Outcome
Measured over a range of dose levels in subjects with inadequate/partial response to antidepressant therapy during the current episode of MDD.
Interventions
- DRUG Placebo
- DRUG ALKS 5461
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 1 |
What the finished NCT01381107 record still lists
NCT01381107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01381107 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01381107 about?
NCT01381107 is a clinical study titled "ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD". This is a multicenter, randomized, double-blind, placebo-controlled, parallel, multiple dose study designed to evaluate the safety and tolerability of the co-formulation of ALKS 33 with buprenorphine (ALKS 5461) in subjects with Major Depressive Disorder (MDD) who are inadequately/partially respondi...
What is the current status of trial NCT01381107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01381107?
The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT01381107?
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 NCT01381107's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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