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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 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.

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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

Conditions Studied

Schizophrenia

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

FieldValue
Enrollment Target 522 participants
Start Date 2025-02-28
Est. Completion 2026-10-29
Phase Phase 3

Sponsor

Otsuka Pharmaceutical Development & Commercialization

221 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06894212

The ClinicalTrials.gov registry entry for NCT06894212 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (141% higher). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.