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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 is a Phase 1 study that has completed, run by Alkermes. The registered enrollment target is 32 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01381107
The ClinicalTrials.gov registry entry for NCT01381107 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alkermes, which has 66 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01381107 reports 0 study locations.
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.
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