ALK33BUP-201: Safety and Tolerability Study of ALKS 33-BUP (ALKS 5461) Administration in Subjects With MDD
Public ClinicalTrials.gov record NCT01381107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ALKS 33-BUP Administration in Subjects With Major Depressive Disorder (MDD)
Study identification
- NCT ID
- NCT01381107
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Lead sponsor
- Alkermes, Inc.
- Industry
- Enrollment
- 32 participants
Conditions and interventions
Conditions
Interventions
- ALKS 5461 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2011
- Primary completion
- Jun 30, 2011
- Completion
- Jun 30, 2011
- Last update posted
- Aug 22, 2011
2011
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Comprehensive NeuroScience, Inc. | St. Petersburg | Florida | 33716 | — |
| Comprehensive NeuroScience, Inc. | Atlanta | Georgia | 30328 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01381107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 22, 2011 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01381107 live on ClinicalTrials.gov.