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NCT02969382 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia
A Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 2
- Development phase
- 245
- Enrollment target
NCT02969382: Completed Phase 2 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02969382 is a Phase 2 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 245 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02969382, a Phase 2 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 245 participants
- Enrollment target
Study Summary
A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia
Primary Outcome
PANSS comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS tot
Interventions
- DRUG SEP-363856
- DRUG Placebo - Cap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 245 participants |
| Start Date | 2016-12-05 |
| Est. Completion | 2018-07-31 |
| Phase | Phase 2 |
What the finished NCT02969382 record still lists
NCT02969382 is an interventional study that assigns participants to a tested intervention. The registered 245 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 (84% higher).
The record links to 0 conditions, and to 2 interventions - of which SEP-363856 is the first listed.
NCT02969382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02969382 about?
NCT02969382 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Adults With Schizophrenia". A study to evaluate the efficacy and safety of an experimental drug (SEP-363856) in acutely psychotic adults with schizophrenia
What is the current status of trial NCT02969382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 245 participants. The study started on 2016-12-05. Estimated completion is 2018-07-31.
What interventions are being tested in trial NCT02969382?
The interventions under investigation include: SEP-363856 (DRUG), Placebo - Cap (DRUG).
Who is sponsoring clinical trial NCT02969382?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02969382's enrollment target sits among peer trials
245 234th of 2000 higher than 1,766 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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