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NCT06894212 · ClinicalTrials.gov registry record · Phase 3
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 522
- Enrollment target
- 20
- Study locations
NCT06894212: Recruiting Phase 3 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT06894212 is a Phase 3 study of Schizophrenia that is actively recruiting participants, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 522 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06894212, a Phase 3 study of Schizophrenia, is actively recruiting participants, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 522 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Primary Outcome
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology
Conditions Studied
Interventions
- OTHER Placebo
- DRUG SEP-363856
Study Locations (20)
California
- Clinical Innovations, Inc. dba CITrials (Bellflower) Site #131 - Bellflower
- ProScience Research Group Site #134 - Culver City
- CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site #123 - Garden Grove
- Synergy San Diego Site #128 - Lemon Grove
- Catalina Research Institute Site #142 - Montclair
- Clinical Innovations Inc. DBA CITrials (Riverside) Site #151 - Riverside
- Richmond Behavioral Associates LLC Site # 136 - Riverside
- CNRI - San Diego LLC Site # 126 - San Diego
- Schuster Medical Research Institute Site # 130 - Sherman Oaks
- CenExel CNS - Los Alamitos (Collaborative Neuroscience Research) Site #149 - Torrance
Florida
- Galiz Research Site #146 - Hialeah
- Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site #147 - Hollywood
- Cenexel RCA (Research Centers of America) Site #124 - Hollywood
- Premier Clinical Research Institute - Site #150 - Miami
- D & H National Research Centers NC Site #143 - Miami
- Innovative Clinical Research, Inc. Site # 125 - Miami Lakes
Arkansas
- Pillar Clinical Research LLC - Bentonville Site # 145 - Bentonville
- Pillar Clinical Research (Little Rock AR) Site #153 - Little Rock
- Woodland International Research Group Site #141 - Little Rock
- Woodland Research Northwest Site # 138 - Rogers
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2025-02-28 |
| Est. Completion | 2026-10-29 |
| Phase | Phase 3 |
What NCT06894212 shows while recruiting
NCT06894212 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06894212 names 20 study sites across 3 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06894212 about?
NCT06894212 is a clinical study titled "A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia". Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
What is the current status of trial NCT06894212?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 522 participants. The study started on 2025-02-28. Estimated completion is 2026-10-29.
What conditions does trial NCT06894212 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT06894212?
The interventions under investigation include: Placebo (OTHER), SEP-363856 (DRUG).
Who is sponsoring clinical trial NCT06894212?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06894212 being conducted?
This trial has 20 study locations across Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
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 NCT06894212's enrollment target sits among peer trials
522 37th of 315 higher than 279 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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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