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NCT01903837 · ClinicalTrials.gov registry record · Phase 2
A Study of ALKS 3831 in Adults With Schizophrenia
A Phase 2 study, sponsored by Alkermes.
- Completed
- Registry status
- Phase 2
- Development phase
- 347
- Enrollment target
NCT01903837: Completed Phase 2 study, sponsored by Alkermes.
NCT01903837 is a Phase 2 study that has completed, run by Alkermes. The registered enrollment target is 347 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (161% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01903837, a Phase 2 study, has completed, sponsored by Alkermes.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 347 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
Primary Outcome
Change from baseline (Day 8) to Day 92 (end of study Part A). The PANSS is a 30-item scale measuring severity of schizophrenia symptoms. Symptom severity for each item is rated on a 7-point scale (1 = absent; 7 = extreme), and the total score is added together, with a minimum score of 30 and a maximum score of 210. A higher score indicates more severe symptoms, while a lower score indicates less severe symptoms.
Interventions
- DRUG Placebo
- DRUG Olanzapine
- DRUG Samidorphan (Low Dose)
- DRUG Samidorphan (Medium Dose)
- DRUG Samidorphan (High Dose)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-03 |
| Phase | Phase 2 |
What the finished NCT01903837 record still lists
NCT01903837 is an interventional study that assigns participants to a tested intervention. The registered 347 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (161% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01903837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01903837 about?
NCT01903837 is a clinical study titled "A Study of ALKS 3831 in Adults With Schizophrenia". This is a Phase 2, randomized, placebo-controlled multicenter study, which will be conducted in 2 parts. The study duration for each subject will be approximately 33 weeks and will include 25 study visits.
What is the current status of trial NCT01903837?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 347 participants. The study started on 2013-06. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01903837?
The interventions under investigation include: Placebo (DRUG), Olanzapine (DRUG), Samidorphan (Low Dose) (DRUG), Samidorphan (Medium Dose) (DRUG), Samidorphan (High Dose) (DRUG).
Who is sponsoring clinical trial NCT01903837?
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 NCT01903837's enrollment target sits among peer trials
347 136th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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