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NCT01500200 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
A Phase 2 study of Major Depressive Disorder, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
- 20
- Study locations
NCT01500200: Completed Phase 2 study of Major Depressive Disorder, sponsored by Alkermes.
NCT01500200 is a Phase 2 study of Major Depressive Disorder that has completed, run by Alkermes. The registered enrollment target is 142 participants, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01500200, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
Primary Outcome
The HAM-D17 scale is a clinician-administered questionnaire comprised of 17 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 50 (most severe symptoms). Individual questionnaire items include depressed mood, work and activities, insomnia (early), insomnia (middle), insomnia (late), genital symptoms, somatic symptoms (gastrointestinal), loss of weight, somatic symptoms (general), feelings of guilt, suicide, anxiety (psychic), anxiety (somatic), hypo
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALKS 5461
Study Locations (20)
Florida
- Alkermes Investigational Site - Fort Myers
- Alkermes Investigational Site - Lauderhill
- Alkermes Investigational Site - Leesburg
- Alkermes Investigational Site - North Miami
- Alkermes Investigational Site - St. Petersburg
California
- Alkermes Investigational Site - Oceanside
- Alkermes Investigational Site - Santa Ana
- Alkermes Investigational Site - Torrance
Massachusetts
- Alkermes Investigational Site - Boston
- Alkermes Investigational Site - Haverhill
New York
- Alkermes Investigational Site - Brooklyn
- Alkermes Investigational Site - New York
Ohio
- Alkermes Investigational Site - Canton
- Alkermes Investigational Site - Dayton
Arizona
- Alkermes Investigational Site - Tucson
Georgia
- Alkermes Investigational Site - Atlanta
Illinois
- Alkermes Investigational Site - Hoffman Estates
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT01500200 record still lists
NCT01500200 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 376-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01500200 names 20 study sites across 11 states, led by Florida, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01500200 about?
NCT01500200 is a clinical study titled "A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)". This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant therapy.
What is the current status of trial NCT01500200?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2011-12. Estimated completion is 2013-03.
What conditions does trial NCT01500200 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT01500200?
The interventions under investigation include: Placebo (DRUG), ALKS 5461 (DRUG).
Who is sponsoring clinical trial NCT01500200?
This trial is sponsored by Alkermes, which has 66 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01500200 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01500200's enrollment target sits among peer trials
142 107th of 282 higher than 176 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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