New schizophrenia drug ulotaront enters final testing phase

NCT ID NCT06894212

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

First seen Nov 01, 2025 · Last updated May 12, 2026 · Updated 24 times

Summary

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

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Contacts and locations

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Study contacts

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Phone: •••-•••-•••• Email: •••••@•••••

Locations

Accelerated Clinical Trials in Peachtree Corners GA Site
RECRUITING

Peachtree Corners, Georgia, 30071, United States

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Asuka Hospital
RECRUITING

Machida-shi, Tokyo, 194-0005, Japan

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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
RECRUITING

Atlanta, Georgia, 30331, United States

Contact
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)
ACTIVE_NOT_RECRUITING

Riverside, California, 92506, United States
Clinical Innovations, Inc. dba CITrials (Bellflower)
RECRUITING

Bellflower, California, 90706, United States

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Community Clinical Research Inc
RECRUITING

Austin, Texas, 78754, United States

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D & H National Research Centers NC
ACTIVE_NOT_RECRUITING

Miami, Florida, 33155, United States
Dokkyo Medical University Hospital
NOT_YET_RECRUITING

Shimotsuga-gun, Tochigi, 321-0293, Japan

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Eastern Clinical Research Associates
ACTIVE_NOT_RECRUITING

New Orleans, Louisiana, 70127, United States
Fujimidai Hospital Site
RECRUITING

Hiratsuka-shi, Kanagawa, 259-1205, Japan

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Fukuoka University Hospital
RECRUITING

Fukuoka, Fukuoka, 814-0180, Japan

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Galiz Research Site
ACTIVE_NOT_RECRUITING

Hialeah, Florida, 33016, United States
Goryokai Medical Corporation Hospital
RECRUITING

Sapporo, Hokkaido, 002-8029, Japan

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HD Research - Memorial Hermann Surgery Center Memorial Village
ACTIVE_NOT_RECRUITING

Houston, Texas, 77043, United States
Hassman Research Institute, LLC
RECRUITING

Marlton, New Jersey, 20877, United States

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Hatano Kousei Hospital
RECRUITING

Hadano-shi, Kanagawa, 257-0003, Japan

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Hayakawa Clinic
RECRUITING

Kure, Hiroshima, 737-0111, Japan

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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

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InSite Clinical Research
ACTIVE_NOT_RECRUITING

DeSoto, Texas, 75115, United States
Innovative Clinical Research, Inc. Site
RECRUITING

Miami Lakes, Florida, 33016, United States

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Inuo Hospital
RECRUITING

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

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Iwate Medical University Hospital
RECRUITING

Shiwa-gun, Iwate, 028-3695, Japan

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Jichi Medical University Hospital
RECRUITING

Shimotsuke-Shi, Tochigi, 329-0498, Japan

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Kansai Medical University Medical Center
RECRUITING

Moriguchi-shi, Osaka, 570-8507, Japan

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Kuramitsu Hospital
RECRUITING

Fukuoka, Fukuoka, 819-0037, Japan

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Miyakonojo Shinsei Hospital
RECRUITING

Miyakonojo-shi, Miyazaki, 885-0093, Japan

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NHO Kure Medical Center
RECRUITING

Kure-shi, Hiroshima, 737-0023, Japan

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National Center of Neurology and Psychiatry
NOT_YET_RECRUITING

Kodaira-shi, Tokyo, 187-8551, Japan

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National Hospital Organization Hizen Psychiatric Medical Center Site
RECRUITING

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

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National Hospital Organization Kokura Medical Center Site
RECRUITING

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

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National Hospital Organization Shimofusa Psychiatric Medical Center
RECRUITING

Chiba, Chiba, 266-0007, Japan

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National Kohnodai Medical Center
RECRUITING

Ichikawa-shi, Chiba, 272-8516, Japan

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Nayoro City General Hospital
RECRUITING

Nayoro-shi, Hokkaido, 096-8511, Japan

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Neuro-Behavioral Clinical Research Site
ACTIVE_NOT_RECRUITING

Canton, Ohio, 44720, United States
Neyagawa Sanatorium
RECRUITING

Neyagawa, Osaka, 572-0854, Japan

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Obihiro Kosei Hospital
RECRUITING

Obihiro, Hokkaido, 080-0024, Japan

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Pillar Clinical Research (Little Rock AR) Site
RECRUITING

Little Rock, Arkansas, 72204, United States

Contact
Pillar Clinical Research LLC (Chicago)
ACTIVE_NOT_RECRUITING

Chicago, Illinois, 60641, United States
Pillar Clinical Research LLC (Richardson, TX) Site
RECRUITING

Richardson, Texas, 75080, United States

Contact
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

Contact
Richmond Behavioral Associates LLC
ACTIVE_NOT_RECRUITING

Riverside, California, 92506, United States
Sanyo Hospital
RECRUITING

Sakata-shi, Yamagata, 998-0074, Japan

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Schuster Medical Research Institute
RECRUITING

Sherman Oaks, California, 91403, United States

Contact
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

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Seishinkai Okehazama Hospital
RECRUITING

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

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Shiga University of Medical Science Hospital
RECRUITING

Ōtsu, Shiga, 520-2192, Japan

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Shiranui Hospital
RECRUITING

Omuta-shi, Fukuoka, 836-0004, Japan

Contact Phone: •••-•••-•••• Email: •••••@•••••
Showa Medical University Karasuyama Hospital
RECRUITING

Setagaya-ku, Tokyo, 157-8577, Japan

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Social Medical Corporation Asaka Hospital
RECRUITING

Kōriyama, Fukushima, 963-0198, Japan

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Synergy San Diego Site
WITHDRAWN

Lemon Grove, California, 91945, United States
Synexus Clinical Research US Inc - Atlanta
RECRUITING

Atlanta, Georgia, 30328, United States

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Tanzawa Hospital
RECRUITING

Hadano-shi, Kanagawa, 259-1304, Japan

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Tochigi Prefectural Okamotodai Hospital
RECRUITING

Utsunomiya, Tochigi, 329-1104, Japan

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Toyama Prefectural Center Hospital
RECRUITING

Toyama, Toyama, 930-8550, Japan

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Uptown Research Institute
RECRUITING

Chicago, Illinois, 60640, United States

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Wakayama Medical University Hospital
RECRUITING

Wakayama, 641-8510, Japan

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Woodland International Research Group Site
RECRUITING

Little Rock, Arkansas, 72211, United States

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Woodland Research Northwest Site
RECRUITING

Rogers, Arkansas, 72758, United States

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Yamagata Sakuracho Hospital Site
RECRUITING

Yamagata, Yamagata, 990-0045, Japan

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Yokohama Hino Hospital
RECRUITING

Yokohama, Kanagawa, 234-0051, Japan

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Yuge Hospital
RECRUITING

Kumamoto, Kumamoto, 861-8002, Japan

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Conditions

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SCHIZOPHRENIA