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NCT04092686 · ClinicalTrials.gov registry record · Phase 3
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
A Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 3
- Development phase
- 464
- Enrollment target
NCT04092686: Completed Phase 3 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT04092686 is a Phase 3 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 464 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04092686, a Phase 3 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 464 participants
- Enrollment target
Study Summary
A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
Primary Outcome
PANSS was an interview-based assessment comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). The Positive subscale assessed hallucinations, delusions, and related symptoms; the Negative subscale assessed emotional withdrawal, lack of motivation, and similar symptoms; and the General Psychopathology subscale addressed other symptoms such as anxiety, somatic concern, and disorientation. An anchored Likert scale from 1 - 7, where values of 2 and above indicated the p
Interventions
- DRUG Placebo
- DRUG SEP-363856 75mg
- DRUG SEP-363856 100mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 464 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2023-06-14 |
| Phase | Phase 3 |
What the finished NCT04092686 record still lists
NCT04092686 is an interventional study that assigns participants to a tested intervention. The registered 464 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04092686 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04092686 about?
NCT04092686 is a clinical study titled "A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia". A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been ...
What is the current status of trial NCT04092686?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 464 participants. The study started on 2019-10-14. Estimated completion is 2023-06-14.
What interventions are being tested in trial NCT04092686?
The interventions under investigation include: Placebo (DRUG), SEP-363856 75mg (DRUG), SEP-363856 100mg (DRUG).
Who is sponsoring clinical trial NCT04092686?
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 NCT04092686's enrollment target sits among peer trials
464 821st of 2000 higher than 1,180 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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