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
1 other identifier
interventional
522
2 countries
73
Brief Summary
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Feb 2025
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedStudy Start
First participant enrolled
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 29, 2026
April 23, 2026
April 1, 2026
1.6 years
February 27, 2025
April 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
To evaluate the efficacy of SEP-363856 (75 and 100 mg/day) compared with placebo in acutely psychotic participants with schizophrenia. PANSS total - 30-210 Higher score is indicative of greater symptomatology
Baseline to Week 6
Secondary Outcomes (1)
Clinical Global Impression-Severity (CGI-S)
Baseline to Week 6
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
SEP-363856 75 mg
EXPERIMENTALSEP-363856 75 mg/day
SEP-363856 100 mg
EXPERIMENTALSEP-363856 100 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
- The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
- 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:
- Participant must have a PANSS total score ≥ 80
- AND
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Pillar Clinical Research LLC - Bentonville Site
Bentonville, Arkansas, 72712, United States
Pillar Clinical Research (Little Rock AR) Site
Little Rock, Arkansas, 72204, United States
Woodland International Research Group Site
Little Rock, Arkansas, 72211, United States
Woodland Research Northwest Site
Rogers, Arkansas, 72758, United States
Clinical Innovations, Inc. dba CITrials (Bellflower)
Bellflower, California, 90706, United States
ProScience Research Group Site
Culver City, California, 90230, United States
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
Garden Grove, California, 92845, United States
Synergy San Diego Site
Lemon Grove, California, 91945, United States
Catalina Research Institute Site
Montclair, California, 91763, United States
Clinical Innovations Inc. DBA CITrials (Riverside)
Riverside, California, 92506, United States
Richmond Behavioral Associates LLC
Riverside, California, 92506, United States
CNRI - San Diego LLC Site
San Diego, California, 92123, United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403, United States
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
Torrance, California, 90504, United States
Galiz Research Site
Hialeah, Florida, 33016, United States
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
Hollywood, Florida, 33021, United States
Cenexel RCA (Research Centers of America) Site
Hollywood, Florida, 33024, United States
Premier Clinical Research Institute
Miami, Florida, 33122, United States
D & H National Research Centers NC
Miami, Florida, 33155, United States
Innovative Clinical Research, Inc. Site
Miami Lakes, Florida, 33016, United States
Health Synergy Clinical Research LLC Site
West Palm Beach, Florida, 33407, United States
Synexus Clinical Research US Inc - Atlanta
Atlanta, Georgia, 30328, United States
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
Atlanta, Georgia, 30331, United States
CenExel IRA (CenExcel iResearch, LLC) Site
Decatur, Georgia, 30030, United States
Accelerated Clinical Trials in Peachtree Corners GA Site
Peachtree Corners, Georgia, 30071, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
Pillar Clinical Research LLC (Chicago)
Chicago, Illinois, 60641, United States
Eastern Clinical Research Associates
New Orleans, Louisiana, 70127, United States
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, 20877, United States
Hassman Research Institute, LLC
Marlton, New Jersey, 20877, United States
Neuro-Behavioral Clinical Research Site
Canton, Ohio, 44720, United States
Community Clinical Research Inc
Austin, Texas, 78754, United States
InSite Clinical Research
DeSoto, Texas, 75115, United States
HD Research - Memorial Hermann Surgery Center Memorial Village
Houston, Texas, 77043, United States
Pillar Clinical Research LLC (Richardson, TX) Site
Richardson, Texas, 75080, United States
Hotei Hospital
Konan-shi, Aichi-ken, 483-8248, Japan
Seishinkai Okehazama Hospital
Toyoake-shi, Aichi-ken, 470-1168, Japan
Seijinkai Seinan Hospital
Hachinohe-shi, Aomori, 039-1104, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, Chiba, 266-0007, Japan
National Kohnodai Medical Center
Ichikawa-shi, Chiba, 272-8516, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180, Japan
Kuramitsu Hospital
Fukuoka, Fukuoka, 819-0037, Japan
National Hospital Organization Kokura Medical Center Site
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, 802-8533, Japan
Shiranui Hospital
Omuta-shi, Fukuoka, 836-0004, Japan
Social Medical Corporation Asaka Hospital
Kōriyama, Fukushima, 963-0198, Japan
Hayakawa Clinic
Kure, Hiroshima, 737-0111, Japan
NHO Kure Medical Center
Kure-shi, Hiroshima, 737-0023, Japan
Nayoro City General Hospital
Nayoro-shi, Hokkaido, 096-8511, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, 080-0024, Japan
Goryokai Medical Corporation Hospital
Sapporo, Hokkaido, 002-8029, Japan
Iwate Medical University Hospital
Shiwa-gun, Iwate, 028-3695, Japan
Hatano Kousei Hospital
Hadano-shi, Kanagawa, 257-0003, Japan
Tanzawa Hospital
Hadano-shi, Kanagawa, 259-1304, Japan
Fujimidai Hospital Site
Hiratsuka-shi, Kanagawa, 259-1205, Japan
Yokohama Hino Hospital
Yokohama, Kanagawa, 234-0051, Japan
Yuge Hospital
Kumamoto, Kumamoto, 861-8002, Japan
Miyakonojo Shinsei Hospital
Miyakonojo-shi, Miyazaki, 885-0093, Japan
Kansai Medical University Medical Center
Moriguchi-shi, Osaka, 570-8507, Japan
Neyagawa Sanatorium
Neyagawa, Osaka, 572-0854, Japan
National Hospital Organization Hizen Psychiatric Medical Center Site
Kanzaki-gun, Saga-ken, 842-0192, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031, Japan
Inuo Hospital
Tosu-shi, Saga-ken, 841-0081, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, 520-2192, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, 321-0293, Japan
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, 329-0498, Japan
Tochigi Prefectural Okamotodai Hospital
Utsunomiya, Tochigi, 329-1104, Japan
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo, 187-8551, Japan
Asuka Hospital
Machida-shi, Tokyo, 194-0005, Japan
Showa Medical University Karasuyama Hospital
Setagaya-ku, Tokyo, 157-8577, Japan
Toyama Prefectural Center Hospital
Toyama, Toyama, 930-8550, Japan
Sanyo Hospital
Sakata-shi, Yamagata, 998-0074, Japan
Yamagata Sakuracho Hospital Site
Yamagata, Yamagata, 990-0045, Japan
Wakayama Medical University Hospital
Wakayama, 641-8510, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 25, 2025
Study Start
February 28, 2025
Primary Completion (Estimated)
October 20, 2026
Study Completion (Estimated)
October 29, 2026
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on the Vivli data sharing platform which can be found here: http://vivli.org/ourmember/Otsuka/
Anonymized Individual participant data (IPD) that underlie the result of this study will be shared with researchers to achieve aims pre-specified in a methodology sound research proposal. Small studies with less than 25 participants are excluded from data sharing.