New schizophrenia pill shows promise in major trial

NCT ID NCT06894212

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

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.

Get updates

Get notified about this study

Our safety recommendation!

By submitting, you agree to our Terms of use

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.