RecruitingPhase 3NCT06894212

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

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

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Enrollment

522 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

Summary

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the effectiveness and safety of a drug called SEP-363856 (ulotaront) in people who are experiencing an acute flare-up of schizophrenia and need hospitalization. SEP-363856 works differently from most antipsychotic medications and may offer a new approach to treatment. **You may be eligible if...** - You are 18–65 years old - You have a diagnosis of schizophrenia and are currently experiencing a significant worsening of psychotic symptoms - You have been hospitalized for this episode, or were already hospitalized for less than 2 weeks at the time of screening - You have a reliable person (caregiver, family member, or case worker) who can provide information about you **You may NOT be eligible if...** - You do not have a confirmed diagnosis of schizophrenia - Your symptoms have been worsening for more than 2 months before screening - You have serious medical conditions that make this treatment unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSEP-363856

tablet

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06894212

Related Trials

Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

NCT074679937 locations

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

NCT0737982745 locations

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

NCT0710109418 locations

A Study to Evaluate the Effect of KarXT on Urological Safety

NCT0722187714 locations

Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical Trial

NCT052081907 locations