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A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
522
Start Date
2025-02-28
Completion Date
2026-10-29
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
SEP-363856
tablet
Placebo
tablet
Locations (73)
Pillar Clinical Research LLC - Bentonville Site
Bentonville, Arkansas, United States
Pillar Clinical Research (Little Rock AR) Site
Little Rock, Arkansas, United States
Woodland International Research Group Site
Little Rock, Arkansas, United States
Woodland Research Northwest Site
Rogers, Arkansas, United States
Clinical Innovations, Inc. dba CITrials (Bellflower)
Bellflower, California, United States
ProScience Research Group Site
Culver City, California, United States
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
Garden Grove, California, United States
Synergy San Diego Site
Lemon Grove, California, United States
Catalina Research Institute Site
Montclair, California, United States
Clinical Innovations Inc. DBA CITrials (Riverside)
Riverside, California, United States
Richmond Behavioral Associates LLC
Riverside, California, United States
CNRI - San Diego LLC Site
San Diego, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
Torrance, California, United States
Galiz Research Site
Hialeah, Florida, United States
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
Hollywood, Florida, United States
Cenexel RCA (Research Centers of America) Site
Hollywood, Florida, United States
Premier Clinical Research Institute
Miami, Florida, United States
D & H National Research Centers NC
Miami, Florida, United States
Innovative Clinical Research, Inc. Site
Miami Lakes, Florida, United States
Health Synergy Clinical Research LLC Site
West Palm Beach, Florida, United States
Synexus Clinical Research US Inc - Atlanta
Atlanta, Georgia, United States
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
Atlanta, Georgia, United States
CenExel IRA (CenExcel iResearch, LLC) Site
Decatur, Georgia, United States
Accelerated Clinical Trials in Peachtree Corners GA Site
Peachtree Corners, Georgia, United States
Uptown Research Institute
Chicago, Illinois, United States
Pillar Clinical Research LLC (Chicago)
Chicago, Illinois, United States
Eastern Clinical Research Associates
New Orleans, Louisiana, United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, United States
Hassman Research Institute, LLC
Marlton, New Jersey, United States
Neuro-Behavioral Clinical Research Site
Canton, Ohio, United States
Community Clinical Research Inc
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
HD Research - Memorial Hermann Surgery Center Memorial Village
Houston, Texas, United States
Pillar Clinical Research LLC (Richardson, TX) Site
Richardson, Texas, United States
Hotei Hospital
Konan-shi, Aichi-ken, Japan
Seishinkai Okehazama Hospital
Toyoake-shi, Aichi-ken, Japan
Seijinkai Seinan Hospital
Hachinohe-shi, Aomori, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, Chiba, Japan
National Kohnodai Medical Center
Ichikawa-shi, Chiba, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Kuramitsu Hospital
Fukuoka, Fukuoka, Japan
National Hospital Organization Kokura Medical Center Site
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan
Shiranui Hospital
Omuta-shi, Fukuoka, Japan
Social Medical Corporation Asaka Hospital
Kōriyama, Fukushima, Japan
Hayakawa Clinic
Kure, Hiroshima, Japan
NHO Kure Medical Center
Kure-shi, Hiroshima, Japan
Nayoro City General Hospital
Nayoro-shi, Hokkaido, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan
Goryokai Medical Corporation Hospital
Sapporo, Hokkaido, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan
Hatano Kousei Hospital
Hadano-shi, Kanagawa, Japan
Tanzawa Hospital
Hadano-shi, Kanagawa, Japan
Fujimidai Hospital Site
Hiratsuka-shi, Kanagawa, Japan
Yokohama Hino Hospital
Yokohama, Kanagawa, Japan
Yuge Hospital
Kumamoto, Kumamoto, Japan
Miyakonojo Shinsei Hospital
Miyakonojo-shi, Miyazaki, Japan
Kansai Medical University Medical Center
Moriguchi-shi, Osaka, Japan
Neyagawa Sanatorium
Neyagawa, Osaka, Japan
National Hospital Organization Hizen Psychiatric Medical Center Site
Kanzaki-gun, Saga-ken, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan
Inuo Hospital
Tosu-shi, Saga-ken, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, Japan
Tochigi Prefectural Okamotodai Hospital
Utsunomiya, Tochigi, Japan
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo, Japan
Asuka Hospital
Machida-shi, Tokyo, Japan
Showa Medical University Karasuyama Hospital
Setagaya-ku, Tokyo, Japan
Toyama Prefectural Center Hospital
Toyama, Toyama, Japan
Sanyo Hospital
Sakata-shi, Yamagata, Japan
Yamagata Sakuracho Hospital Site
Yamagata, Yamagata, Japan
Wakayama Medical University Hospital
Wakayama, Japan