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

October 2, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
538

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • Japan
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital
    • Aichi-ken
      • Konan-shi, Aichi-ken, Japan, 483-8248
        • Hotei Hospital
      • Toyoake-shi, Aichi-ken, Japan, 470-1168
        • Seishinkai Okehazama Hospital
    • Aomori
      • Hachinohe-shi, Aomori, Japan, 039-1104
        • Seijinkai Seinan Hospital
    • Chiba
      • Chiba, Chiba, Japan, 266-0007
        • National Hospital Organization Shimofusa Psychiatric Medical Center
      • Ichikawa-shi, Chiba, Japan, 272-8516
        • National Kohnodai Medical Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Fukuoka, Fukuoka, Japan, 819-0037
        • Kuramitsu Hospital
      • Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
        • National Hospital Organization Kokura Medical Center Site
      • Omuta-shi, Fukuoka, Japan, 836-0004
        • Shiranui Hospital
    • Fukushima
      • Kōriyama, Fukushima, Japan, 963-0198
        • Social Medical Corporation Asaka Hospital
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0111
        • Hayakawa Clinic
      • Kure-shi, Hiroshima, Japan, 737-0023
        • NHO Kure Medical Center
    • Hokkaido
      • Nayoro-shi, Hokkaido, Japan, 096-8511
        • Nayoro City General Hospital
      • Obihiro, Hokkaido, Japan, 080-0024
        • Obihiro Kosei Hospital
      • Sapporo, Hokkaido, Japan, 002-8029
        • Goryokai Medical Corporation Hospital
    • Iwate
      • Shiwa-gun, Iwate, Japan, 028-3695
        • Iwate Medical University Hospital
    • Kanagawa
      • Hadano-shi, Kanagawa, Japan, 257-0003
        • Hatano Kousei Hospital
      • Hadano-shi, Kanagawa, Japan, 259-1304
        • Tanzawa Hospital
      • Hiratsuka-shi, Kanagawa, Japan, 259-1205
        • Fujimidai Hospital Site
      • Yokohama, Kanagawa, Japan, 234-0051
        • Yokohama Hino Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 861-8002
        • Yuge Hospital
    • Miyazaki
      • Miyakonojo-shi, Miyazaki, Japan, 885-0093
        • Miyakonojo Shinsei Hospital
    • Osaka
      • Moriguchi-shi, Osaka, Japan, 570-8507
        • Kansai Medical University Medical Center
      • Neyagawa, Osaka, Japan, 572-0854
        • Neyagawa Sanatorium
    • Saga-ken
      • Kanzaki-gun, Saga-ken, Japan, 842-0192
        • National Hospital Organization Hizen Psychiatric Medical Center Site
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Rainbow and Sea Hospital
      • Tosu-shi, Saga-ken, Japan, 841-0081
        • Inuo Hospital
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science Hospital
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Shimotsuke-Shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Utsunomiya, Tochigi, Japan, 329-1104
        • Tochigi Prefectural Okamotodai Hospital
    • Tokyo
      • Kodaira-shi, Tokyo, Japan, 187-8551
        • National Center of Neurology and Psychiatry
      • Machida-shi, Tokyo, Japan, 194-0005
        • Asuka Hospital
      • Setagaya-ku, Tokyo, Japan, 157-8577
        • Showa Medical University Karasuyama Hospital
    • Toyama
      • Toyama, Toyama, Japan, 930-8550
        • Toyama Prefectural Center Hospital
    • Yamagata
      • Sakata-shi, Yamagata, Japan, 998-0074
        • Sanyo Hospital
      • Yamagata, Yamagata, Japan, 990-0045
        • Yamagata Sakuracho Hospital Site
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Pillar Clinical Research LLC - Bentonville Site
      • Little Rock, Arkansas, United States, 72204
        • Pillar Clinical Research (Little Rock AR) Site
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group Site
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest Site
    • California
      • Bellflower, California, United States, 90706
        • Clinical Innovations, Inc. dba CITrials (Bellflower)
      • Culver City, California, United States, 90230
        • ProScience Research Group Site
      • Garden Grove, California, United States, 92845
        • CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
      • Lemon Grove, California, United States, 91945
        • Synergy San Diego Site
      • Montclair, California, United States, 91763
        • Catalina Research Institute Site
      • Riverside, California, United States, 92506
        • Clinical Innovations Inc. DBA CITrials (Riverside)
      • Riverside, California, United States, 92506
        • Richmond Behavioral Associates LLC
      • San Diego, California, United States, 92123
        • CNRI - San Diego LLC Site
      • Sherman Oaks, California, United States, 91403
        • Schuster Medical Research Institute
      • Torrance, California, United States, 90504
        • CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
    • Florida
      • Hialeah, Florida, United States, 33016
        • Galiz Research Site
      • Hollywood, Florida, United States, 33021
        • Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
      • Hollywood, Florida, United States, 33024
        • Cenexel RCA (Research Centers of America) Site
      • Miami, Florida, United States, 33122
        • Premier Clinical Research Institute
      • Miami, Florida, United States, 33155
        • D & H National Research Centers NC
      • Miami Lakes, Florida, United States, 33016
        • Innovative Clinical Research, Inc. Site
      • West Palm Beach, Florida, United States, 33407
        • Health Synergy Clinical Research LLC Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research US Inc - Atlanta
      • Atlanta, Georgia, United States, 30331
        • CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
      • Decatur, Georgia, United States, 30030
        • CenExel IRA (CenExcel iResearch, LLC) Site
      • Peachtree Corners, Georgia, United States, 30071
        • Accelerated Clinical Trials in Peachtree Corners GA Site
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Uptown Research Institute
      • Chicago, Illinois, United States, 60641
        • Pillar Clinical Research LLC (Chicago)
    • Louisiana
      • New Orleans, Louisiana, United States, 70127
        • Eastern Clinical Research Associates
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Cenexel CBH (CBH Health)
    • New Jersey
      • Marlton, New Jersey, United States, 20877
        • Hassman Research Institute, LLC
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Neuro-Behavioral Clinical Research Site
    • Texas
      • Austin, Texas, United States, 78754
        • Community Clinical Research Inc
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77043
        • HD Research - Memorial Hermann Surgery Center Memorial Village
      • Richardson, Texas, United States, 75080
        • Pillar Clinical Research LLC (Richardson, TX) Site

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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