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New schizophrenia pill shows promise in major trial

NCT ID NCT06894212

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study tests a new drug called Ulotaront (SEP-363856) to see if it can reduce symptoms like hallucinations and delusions in people with schizophrenia. About 522 adults experiencing an acute episode will receive either the drug or a placebo for 6 weeks. The main goal is to measure symptom changes using a standard rating scale.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ulotaront (SEP-363856) tablet
What this could lead to
If it works, this could provide a new treatment option to reduce schizophrenia symptoms like hallucinations and delusions.
What could go wrong
This is an early Phase 3 trial, so results may not confirm benefit. Side effects are possible, and the drug may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 522 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Accelerated Clinical Trials in Peachtree Corners GA Site

    ACTIVE_NOT_RECRUITING

    Peachtree Corners, Georgia, 30071, United States

  • Asuka Hospital

    RECRUITING

    Machida-shi, Tokyo, 194-0005, Japan

  • CNRI - San Diego LLC Site

    ACTIVE_NOT_RECRUITING

    San Diego, California, 92123, United States

  • Catalina Research Institute Site

    ACTIVE_NOT_RECRUITING

    Montclair, California, 91763, United States

  • CenExel ACMR (Atlanta Center for Medical Research, LLC) Site

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30331, United States

  • CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site

    ACTIVE_NOT_RECRUITING

    Garden Grove, California, 92845, United States

  • CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)

    ACTIVE_NOT_RECRUITING

    Torrance, California, 90504, United States

  • CenExel IRA (CenExcel iResearch, LLC) Site

    ACTIVE_NOT_RECRUITING

    Decatur, Georgia, 30030, United States

  • Cenexel CBH (CBH Health)

    ACTIVE_NOT_RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Cenexel RCA (Research Centers of America) Site

    ACTIVE_NOT_RECRUITING

    Hollywood, Florida, 33024, United States

  • Clinical Innovations Inc. DBA CITrials (Riverside)

    COMPLETED

    Riverside, California, 92506, United States

  • Clinical Innovations, Inc. dba CITrials (Bellflower)

    ACTIVE_NOT_RECRUITING

    Bellflower, California, 90706, United States

  • Community Clinical Research Inc

    ACTIVE_NOT_RECRUITING

    Austin, Texas, 78754, United States

  • D & H National Research Centers NC

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33155, United States

  • Dokkyo Medical University Hospital

    RECRUITING

    Shimotsuga-gun, Tochigi, 321-0293, Japan

  • Eastern Clinical Research Associates

    ACTIVE_NOT_RECRUITING

    New Orleans, Louisiana, 70127, United States

  • Fujimidai Hospital Site

    RECRUITING

    Hiratsuka-shi, Kanagawa, 259-1205, Japan

  • Fukuoka University Hospital

    RECRUITING

    Fukuoka, Fukuoka, 814-0180, Japan

  • Galiz Research Site

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33016, United States

  • Goryokai Medical Corporation Hospital

    RECRUITING

    Sapporo, Hokkaido, 002-8029, Japan

  • HD Research - Memorial Hermann Surgery Center Memorial Village

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77043, United States

  • Hassman Research Institute, LLC

    ACTIVE_NOT_RECRUITING

    Marlton, New Jersey, 20877, United States

  • Hatano Kousei Hospital

    RECRUITING

    Hadano-shi, Kanagawa, 257-0003, Japan

  • Hayakawa Clinic

    RECRUITING

    Kure, Hiroshima, 737-0111, Japan

  • Health Synergy Clinical Research LLC Site

    ACTIVE_NOT_RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Hotei Hospital

    RECRUITING

    Konan-shi, Aichi-ken, 483-8248, Japan

  • InSite Clinical Research

    ACTIVE_NOT_RECRUITING

    DeSoto, Texas, 75115, United States

  • Innovative Clinical Research, Inc. Site

    ACTIVE_NOT_RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Inuo Hospital

    RECRUITING

    Tosu-shi, Saga-ken, 841-0081, Japan

  • Iwate Medical University Hospital

    RECRUITING

    Shiwa-gun, Iwate, 028-3695, Japan

  • Jichi Medical University Hospital

    RECRUITING

    Shimotsuke-Shi, Tochigi, 329-0498, Japan

  • Kansai Medical University Medical Center

    RECRUITING

    Moriguchi-shi, Osaka, 570-8507, Japan

  • Kuramitsu Hospital

    RECRUITING

    Fukuoka, Fukuoka, 819-0037, Japan

  • Miyakonojo Shinsei Hospital

    RECRUITING

    Miyakonojo-shi, Miyazaki, 885-0093, Japan

  • NHO Kure Medical Center

    RECRUITING

    Kure-shi, Hiroshima, 737-0023, Japan

  • National Center of Neurology and Psychiatry

    RECRUITING

    Kodaira-shi, Tokyo, 187-8551, Japan

  • National Hospital Organization Hizen Psychiatric Medical Center Site

    RECRUITING

    Kanzaki-gun, Saga-ken, 842-0192, Japan

  • National Hospital Organization Kokura Medical Center Site

    RECRUITING

    Kokuraminami-ku, Kitakyushu-shi, Fukuoka, 802-8533, Japan

  • National Hospital Organization Shimofusa Psychiatric Medical Center

    RECRUITING

    Chiba, Chiba, 266-0007, Japan

  • National Kohnodai Medical Center

    RECRUITING

    Ichikawa-shi, Chiba, 272-8516, Japan

  • Nayoro City General Hospital

    RECRUITING

    Nayoro-shi, Hokkaido, 096-8511, Japan

  • Neuro-Behavioral Clinical Research Site

    ACTIVE_NOT_RECRUITING

    North Canton, Ohio, 44720, United States

  • Neyagawa Sanatorium

    RECRUITING

    Neyagawa, Osaka, 572-0854, Japan

  • Obihiro Kosei Hospital

    RECRUITING

    Obihiro, Hokkaido, 080-0024, Japan

  • Pillar Clinical Research (Little Rock AR) Site

    ACTIVE_NOT_RECRUITING

    Little Rock, Arkansas, 72204, United States

  • Pillar Clinical Research LLC (Chicago)

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60641, United States

  • Pillar Clinical Research LLC (Richardson, TX) Site

    ACTIVE_NOT_RECRUITING

    Richardson, Texas, 75080, United States

  • Pillar Clinical Research LLC - Bentonville Site

    ACTIVE_NOT_RECRUITING

    Bentonville, Arkansas, 72712, United States

  • Premier Clinical Research Institute

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33122, United States

  • ProScience Research Group Site

    ACTIVE_NOT_RECRUITING

    Culver City, California, 90230, United States

  • Rainbow and Sea Hospital

    RECRUITING

    Karatsu-shi, Saga-ken, 847-0031, Japan

  • Richmond Behavioral Associates LLC

    ACTIVE_NOT_RECRUITING

    Riverside, California, 92506, United States

  • Sanyo Hospital

    RECRUITING

    Sakata-shi, Yamagata, 998-0074, Japan

  • Schuster Medical Research Institute

    ACTIVE_NOT_RECRUITING

    Sherman Oaks, California, 91403, United States

  • Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site

    ACTIVE_NOT_RECRUITING

    Hollywood, Florida, 33021, United States

  • Seijinkai Seinan Hospital

    RECRUITING

    Hachinohe-shi, Aomori, 039-1104, Japan

  • Seishinkai Okehazama Hospital

    RECRUITING

    Toyoake-shi, Aichi-ken, 470-1168, Japan

  • Shiga University of Medical Science Hospital

    RECRUITING

    Ōtsu, Shiga, 520-2192, Japan

  • Shiranui Hospital

    RECRUITING

    Omuta-shi, Fukuoka, 836-0004, Japan

  • Showa Medical University Karasuyama Hospital

    RECRUITING

    Setagaya-ku, Tokyo, 157-8577, Japan

  • Social Medical Corporation Asaka Hospital

    RECRUITING

    Kōriyama, Fukushima, 963-0198, Japan

  • Synergy San Diego Site

    WITHDRAWN

    Lemon Grove, California, 91945, United States

  • Synexus Clinical Research US Inc - Atlanta

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30328, United States

  • Tanzawa Hospital

    RECRUITING

    Hadano-shi, Kanagawa, 259-1304, Japan

  • Tochigi Prefectural Okamotodai Hospital

    RECRUITING

    Utsunomiya, Tochigi, 329-1104, Japan

  • Toyama Prefectural Center Hospital

    RECRUITING

    Toyama, Toyama, 930-8550, Japan

  • Uptown Research Institute

    ACTIVE_NOT_RECRUITING

    Chicago, Illinois, 60640, United States

  • Wakayama Medical University Hospital

    RECRUITING

    Wakayama, 641-8510, Japan

  • Woodland International Research Group Site

    ACTIVE_NOT_RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Woodland Research Northwest Site

    ACTIVE_NOT_RECRUITING

    Rogers, Arkansas, 72758, United States

  • Yamagata Sakuracho Hospital Site

    RECRUITING

    Yamagata, Yamagata, 990-0045, Japan

  • Yokohama Hino Hospital

    RECRUITING

    Yokohama, Kanagawa, 234-0051, Japan

  • Yuge Hospital

    RECRUITING

    Kumamoto, Kumamoto, 861-8002, Japan

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