A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

May 13, 2026 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate 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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia

Study Type

Interventional

Enrollment (Estimated)

522

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Otsuka Call Center
    • Aichi-ken
      • Konan-shi, Aichi-ken, Japan, 483-8248
        • Recruiting
        • Hotei Hospital
        • Contact:
          • Otsuka Call Center
      • Toyoake-shi, Aichi-ken, Japan, 470-1168
        • Recruiting
        • Seishinkai Okehazama Hospital
        • Contact:
          • Otsuka Call Center
    • Aomori
      • Hachinohe-shi, Aomori, Japan, 039-1104
        • Recruiting
        • Seijinkai Seinan Hospital
        • Contact:
          • Otsuka Call Center
    • Chiba
      • Chiba, Chiba, Japan, 266-0007
        • Recruiting
        • National Hospital Organization Shimofusa Psychiatric Medical Center
        • Contact:
          • Otsuka Call Center
      • Ichikawa-shi, Chiba, Japan, 272-8516
        • Recruiting
        • National Kohnodai Medical Center
        • Contact:
          • Otsuka Call Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Recruiting
        • Fukuoka University Hospital
        • Contact:
          • Otsuka Call Center
      • Fukuoka, Fukuoka, Japan, 819-0037
        • Recruiting
        • Kuramitsu Hospital
        • Contact:
          • Otsuka Call Center
      • Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
        • Recruiting
        • National Hospital Organization Kokura Medical Center Site
        • Contact:
          • Otsuka Call Center
      • Omuta-shi, Fukuoka, Japan, 836-0004
    • Fukushima
      • Kōriyama, Fukushima, Japan, 963-0198
        • Recruiting
        • Social Medical Corporation Asaka Hospital
        • Contact:
          • Otsuka Call Center
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0111
        • Recruiting
        • Hayakawa Clinic
        • Contact:
          • Otsuka Call Center
      • Kure-shi, Hiroshima, Japan, 737-0023
        • Recruiting
        • NHO Kure Medical Center
        • Contact:
          • Otsuka Call Center
    • Hokkaido
      • Nayoro-shi, Hokkaido, Japan, 096-8511
        • Recruiting
        • Nayoro City General Hospital
        • Contact:
          • Otsuka Call Center
      • Obihiro, Hokkaido, Japan, 080-0024
        • Recruiting
        • Obihiro Kosei Hospital
        • Contact:
          • Otsuka Call Center
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation Hospital
        • Contact:
          • Otsuka Call Center
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Recruiting
        • Iwate Medical University Hospital
        • Contact:
          • Otsuka Call Center
    • Kanagawa
      • Hadano-shi, Kanagawa, Japan, 257-0003
        • Recruiting
        • Hatano Kousei Hospital
        • Contact:
          • Otsuka Call Center
      • Hadano-shi, Kanagawa, Japan, 259-1304
        • Recruiting
        • Tanzawa Hospital
        • Contact:
          • Otsuka Call Center
      • Hiratsuka-shi, Kanagawa, Japan, 259-1205
        • Recruiting
        • Fujimidai Hospital Site
        • Contact:
          • Otsuka Call Center
      • Yokohama, Kanagawa, Japan, 234-0051
        • Recruiting
        • Yokohama Hino Hospital
        • Contact:
          • Otsuka Call Center
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-8002
        • Recruiting
        • Yuge Hospital
        • Contact:
          • Otsuka Call Center
    • Miyazaki
      • Miyakonojo-shi, Miyazaki, Japan, 885-0093
        • Recruiting
        • Miyakonojo Shinsei Hospital
        • Contact:
          • Otsuka Call Center
    • Osaka
      • Moriguchi-shi, Osaka, Japan, 570-8507
        • Recruiting
        • Kansai Medical University Medical Center
        • Contact:
          • Otsuka Call Center
      • Neyagawa, Osaka, Japan, 572-0854
        • Recruiting
        • Neyagawa Sanatorium
        • Contact:
          • Otsuka Call Center
    • Saga-ken
      • Kanzaki-gun, Saga-ken, Japan, 842-0192
        • Recruiting
        • National Hospital Organization Hizen Psychiatric Medical Center Site
        • Contact:
          • Otsuka Call Center
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Otsuka Call Center
      • Tosu-shi, Saga-ken, Japan, 841-0081
        • Recruiting
        • Inuo Hospital
        • Contact:
          • Otsuka Call Center
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Recruiting
        • Shiga University of Medical Science Hospital
        • Contact:
          • Otsuka Call Center
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Not yet recruiting
        • Dokkyo Medical University Hospital
        • Contact:
          • Otsuka Call Center
      • Shimotsuke-Shi, Tochigi, Japan, 329-0498
        • Recruiting
        • Jichi Medical University Hospital
        • Contact:
          • Otsuka Call Center
      • Utsunomiya, Tochigi, Japan, 329-1104
        • Recruiting
        • Tochigi Prefectural Okamotodai Hospital
        • Contact:
          • Otsuka Call Center
    • Tokyo
      • Kodaira-shi, Tokyo, Japan, 187-8551
        • Recruiting
        • National Center of Neurology and Psychiatry
        • Contact:
          • Otsuka Call Center
      • Machida-shi, Tokyo, Japan, 194-0005
        • Recruiting
        • Asuka Hospital
        • Contact:
          • Otsuka Call Center
      • Setagaya-ku, Tokyo, Japan, 157-8577
        • Recruiting
        • Showa Medical University Karasuyama Hospital
        • Contact:
          • Otsuka Call Center
    • Toyama
      • Toyama, Toyama, Japan, 930-8550
        • Recruiting
        • Toyama Prefectural Center Hospital
        • Contact:
          • Otsuka Call Center
    • Yamagata
      • Sakata-shi, Yamagata, Japan, 998-0074
        • Recruiting
        • Sanyo Hospital
        • Contact:
          • Otsuka Call Center
      • Yamagata, Yamagata, Japan, 990-0045
        • Recruiting
        • Yamagata Sakuracho Hospital Site
        • Contact:
          • Otsuka Call Center
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Active, not recruiting
        • Pillar Clinical Research LLC - Bentonville Site
      • Little Rock, Arkansas, United States, 72204
        • Recruiting
        • Pillar Clinical Research (Little Rock AR) Site
        • Contact:
          • Otsuka Call Center
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group Site
        • Contact:
          • Otsuka Call Center
      • Rogers, Arkansas, United States, 72758
        • Recruiting
        • Woodland Research Northwest Site
        • Contact:
          • Otsuka Call Center
    • California
      • Bellflower, California, United States, 90706
        • Recruiting
        • Clinical Innovations, Inc. dba CITrials (Bellflower)
        • Contact:
          • Otsuka Call Center
      • Culver City, California, United States, 90230
        • Active, not recruiting
        • ProScience Research Group Site
      • Garden Grove, California, United States, 92845
        • Active, not recruiting
        • CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
      • Lemon Grove, California, United States, 91945
        • Withdrawn
        • Synergy San Diego Site
      • Montclair, California, United States, 91763
        • Active, not recruiting
        • Catalina Research Institute Site
      • Riverside, California, United States, 92506
        • Active, not recruiting
        • Richmond Behavioral Associates LLC
      • Riverside, California, United States, 92506
        • Completed
        • Clinical Innovations Inc. DBA CITrials (Riverside)
      • San Diego, California, United States, 92123
        • Active, not recruiting
        • CNRI - San Diego LLC Site
      • Sherman Oaks, California, United States, 91403
        • Recruiting
        • Schuster Medical Research Institute
        • Contact:
          • Otsuka Call Center
      • Torrance, California, United States, 90504
        • Active, not recruiting
        • CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
    • Florida
      • Hialeah, Florida, United States, 33016
        • Active, not recruiting
        • Galiz Research Site
      • Hollywood, Florida, United States, 33021
        • Active, not recruiting
        • Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
      • Hollywood, Florida, United States, 33024
        • Active, not recruiting
        • Cenexel RCA (Research Centers of America) Site
      • Miami, Florida, United States, 33122
        • Active, not recruiting
        • Premier Clinical Research Institute
      • Miami, Florida, United States, 33155
        • Active, not recruiting
        • D & H National Research Centers NC
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Innovative Clinical Research, Inc. Site
        • Contact:
          • Otsuka Call Center
      • West Palm Beach, Florida, United States, 33407
        • Active, not recruiting
        • Health Synergy Clinical Research LLC Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Synexus Clinical Research US Inc - Atlanta
        • Contact:
          • Otsuka Call Center
      • Atlanta, Georgia, United States, 30331
        • Recruiting
        • CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
        • Contact:
          • Otsuka Call Center
      • Decatur, Georgia, United States, 30030
        • Active, not recruiting
        • CenExel IRA (CenExcel iResearch, LLC) Site
      • Peachtree Corners, Georgia, United States, 30071
        • Recruiting
        • Accelerated Clinical Trials in Peachtree Corners GA Site
        • Contact:
          • Otsuka Call Center
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Uptown Research Institute
        • Contact:
          • Otsuka Call Center
      • Chicago, Illinois, United States, 60641
        • Active, not recruiting
        • Pillar Clinical Research LLC (Chicago)
    • Louisiana
      • New Orleans, Louisiana, United States, 70127
        • Active, not recruiting
        • Eastern Clinical Research Associates
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Active, not recruiting
        • Cenexel CBH (CBH Health)
    • New Jersey
      • Marlton, New Jersey, United States, 20877
        • Recruiting
        • Hassman Research Institute, LLC
        • Contact:
          • Otsuka Call Center
    • Ohio
      • Canton, Ohio, United States, 44720
        • Active, not recruiting
        • Neuro-Behavioral Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78754
        • Recruiting
        • Community Clinical Research Inc
        • Contact:
          • Otsuka Call Center
      • DeSoto, Texas, United States, 75115
        • Active, not recruiting
        • InSite Clinical Research
      • Houston, Texas, United States, 77043
        • Active, not recruiting
        • HD Research - Memorial Hermann Surgery Center Memorial Village
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research LLC (Richardson, TX) Site
        • Contact:
          • Otsuka Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Male or female participants between 18 to 65 years of age (inclusive) at the time of consent.
  • Participant has an identified reliable informant (eg, caregiver, relative, friend, case worker, residential treatment staff).

  • Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to screening

    1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
    2. If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening.

  • Participants who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting ALL of the following criteria at the screening and baseline visits:

    1. Participant must have a PANSS total score ≥ 80

      AND

    2. Participant must have a CGI-S score ≥ 4.
  • Participants who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response.

Key Exclusion Criteria:

  • Sexually active participants or persons of childbearing potential who do not agree to practice 2 different clinical trial sponsor approved methods of birth control or remain abstinent during the course of the trial and for 30 days after the last dose of study drug.
  • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
  • Participant has had psychiatric hospitalization(s) for more than 30 days (cumulative) during the 90 days prior to screening.
  • Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
tablet
Experimental: SEP-363856 75 mg
SEP-363856 75 mg/day
Drug: SEP-363856
tablet
Experimental: SEP-363856 100 mg
SEP-363856 100 mg/day
Drug: SEP-363856
tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Time Frame: Baseline to Week 6

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
Baseline to Week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Global Impression-Severity (CGI-S)
Time Frame: Baseline to Week 6

Change from baseline in CGI-S score at Week 6.

CGI-S is 0-7 with higher score is indicative of greater symptomatology
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2025

Primary Completion (Estimated)

October 20, 2026

Study Completion (Estimated)

October 29, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 382-201-00035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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