Actively Recruiting
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Led by Otsuka Pharmaceutical Development & Commercialization, Inc. · Updated on 2026-05-14
522
Participants Needed
73
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
CONDITIONS
Official Title
A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
- Participant must have a PANSS total score 60 80 and a CGI-S score 60 4 at screening and baseline visits.
- Participants who have received previous outpatient antipsychotic treatment at an adequate dose for at least 6 weeks and who showed a previous good response.
You will not qualify if you...
- Sexually active participants or persons of childbearing potential who do not agree to practice 2 different sponsor-approved methods of birth control or remain abstinent during the trial and for 30 days after last dose.
- Participant has a current DSM-5 diagnosis or symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- Participant has had psychiatric hospitalization(s) lasting more than 30 days cumulatively during the 90 days prior to screening.
- Participant has previously received SEP-363856 or was previously enrolled in a SEP-363856 clinical study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 73 locations
1
Pillar Clinical Research LLC - Bentonville Site
Bentonville, Arkansas, United States, 72712
Active, Not Recruiting
2
Pillar Clinical Research (Little Rock AR) Site
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Woodland International Research Group Site
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Woodland Research Northwest Site
Rogers, Arkansas, United States, 72758
Actively Recruiting
5
Clinical Innovations, Inc. dba CITrials (Bellflower)
Bellflower, California, United States, 90706
Actively Recruiting
6
ProScience Research Group Site
Culver City, California, United States, 90230
Active, Not Recruiting
7
CenExel CNS - Garden Grove (Collaborative Neuroscience Research) Site
Garden Grove, California, United States, 92845
Active, Not Recruiting
8
Synergy San Diego Site
Lemon Grove, California, United States, 91945
Withdrawn
9
Catalina Research Institute Site
Montclair, California, United States, 91763
Active, Not Recruiting
10
Clinical Innovations Inc. DBA CITrials (Riverside)
Riverside, California, United States, 92506
Completed
11
Richmond Behavioral Associates LLC
Riverside, California, United States, 92506
Active, Not Recruiting
12
CNRI - San Diego LLC Site
San Diego, California, United States, 92123
Active, Not Recruiting
13
Schuster Medical Research Institute
Sherman Oaks, California, United States, 91403
Actively Recruiting
14
CenExel CNS - Los Alamitos (Collaborative Neuroscience Research)
Torrance, California, United States, 90504
Active, Not Recruiting
15
Galiz Research Site
Hialeah, Florida, United States, 33016
Active, Not Recruiting
16
Segal Trials - Larkin Behavioral Health - Inpatient & Early Phase Site
Hollywood, Florida, United States, 33021
Active, Not Recruiting
17
Cenexel RCA (Research Centers of America) Site
Hollywood, Florida, United States, 33024
Active, Not Recruiting
18
Premier Clinical Research Institute
Miami, Florida, United States, 33122
Active, Not Recruiting
19
D & H National Research Centers NC
Miami, Florida, United States, 33155
Active, Not Recruiting
20
Innovative Clinical Research, Inc. Site
Miami Lakes, Florida, United States, 33016
Actively Recruiting
21
Health Synergy Clinical Research LLC Site
West Palm Beach, Florida, United States, 33407
Active, Not Recruiting
22
Synexus Clinical Research US Inc - Atlanta
Atlanta, Georgia, United States, 30328
Actively Recruiting
23
CenExel ACMR (Atlanta Center for Medical Research, LLC) Site
Atlanta, Georgia, United States, 30331
Actively Recruiting
24
CenExel IRA (CenExcel iResearch, LLC) Site
Decatur, Georgia, United States, 30030
Active, Not Recruiting
25
Accelerated Clinical Trials in Peachtree Corners GA Site
Peachtree Corners, Georgia, United States, 30071
Actively Recruiting
26
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
27
Pillar Clinical Research LLC (Chicago)
Chicago, Illinois, United States, 60641
Active, Not Recruiting
28
Eastern Clinical Research Associates
New Orleans, Louisiana, United States, 70127
Active, Not Recruiting
29
Cenexel CBH (CBH Health)
Gaithersburg, Maryland, United States, 20877
Active, Not Recruiting
30
Hassman Research Institute, LLC
Marlton, New Jersey, United States, 20877
Actively Recruiting
31
Neuro-Behavioral Clinical Research Site
Canton, Ohio, United States, 44720
Active, Not Recruiting
32
Community Clinical Research Inc
Austin, Texas, United States, 78754
Actively Recruiting
33
InSite Clinical Research
DeSoto, Texas, United States, 75115
Active, Not Recruiting
34
HD Research - Memorial Hermann Surgery Center Memorial Village
Houston, Texas, United States, 77043
Active, Not Recruiting
35
Pillar Clinical Research LLC (Richardson, TX) Site
Richardson, Texas, United States, 75080
Actively Recruiting
36
Hotei Hospital
Konan-shi, Aichi-ken, Japan, 483-8248
Actively Recruiting
37
Seishinkai Okehazama Hospital
Toyoake-shi, Aichi-ken, Japan, 470-1168
Actively Recruiting
38
Seijinkai Seinan Hospital
Hachinohe-shi, Aomori, Japan, 039-1104
Actively Recruiting
39
National Hospital Organization Shimofusa Psychiatric Medical Center
Chiba, Chiba, Japan, 266-0007
Actively Recruiting
40
National Kohnodai Medical Center
Ichikawa-shi, Chiba, Japan, 272-8516
Actively Recruiting
41
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan, 814-0180
Actively Recruiting
42
Kuramitsu Hospital
Fukuoka, Fukuoka, Japan, 819-0037
Actively Recruiting
43
National Hospital Organization Kokura Medical Center Site
Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan, 802-8533
Actively Recruiting
44
Shiranui Hospital
Omuta-shi, Fukuoka, Japan, 836-0004
Actively Recruiting
45
Social Medical Corporation Asaka Hospital
Kōriyama, Fukushima, Japan, 963-0198
Actively Recruiting
46
Hayakawa Clinic
Kure, Hiroshima, Japan, 737-0111
Actively Recruiting
47
NHO Kure Medical Center
Kure-shi, Hiroshima, Japan, 737-0023
Actively Recruiting
48
Nayoro City General Hospital
Nayoro-shi, Hokkaido, Japan, 096-8511
Actively Recruiting
49
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan, 080-0024
Actively Recruiting
50
Goryokai Medical Corporation Hospital
Sapporo, Hokkaido, Japan, 002-8029
Actively Recruiting
51
Iwate Medical University Hospital
Shiwa-gun, Iwate, Japan, 028-3695
Actively Recruiting
52
Hatano Kousei Hospital
Hadano-shi, Kanagawa, Japan, 257-0003
Actively Recruiting
53
Tanzawa Hospital
Hadano-shi, Kanagawa, Japan, 259-1304
Actively Recruiting
54
Fujimidai Hospital Site
Hiratsuka-shi, Kanagawa, Japan, 259-1205
Actively Recruiting
55
Yokohama Hino Hospital
Yokohama, Kanagawa, Japan, 234-0051
Actively Recruiting
56
Yuge Hospital
Kumamoto, Kumamoto, Japan, 861-8002
Actively Recruiting
57
Miyakonojo Shinsei Hospital
Miyakonojo-shi, Miyazaki, Japan, 885-0093
Actively Recruiting
58
Kansai Medical University Medical Center
Moriguchi-shi, Osaka, Japan, 570-8507
Actively Recruiting
59
Neyagawa Sanatorium
Neyagawa, Osaka, Japan, 572-0854
Actively Recruiting
60
National Hospital Organization Hizen Psychiatric Medical Center Site
Kanzaki-gun, Saga-ken, Japan, 842-0192
Actively Recruiting
61
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan, 847-0031
Actively Recruiting
62
Inuo Hospital
Tosu-shi, Saga-ken, Japan, 841-0081
Actively Recruiting
63
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan, 520-2192
Actively Recruiting
64
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan, 321-0293
Not Yet Recruiting
65
Jichi Medical University Hospital
Shimotsuke-Shi, Tochigi, Japan, 329-0498
Actively Recruiting
66
Tochigi Prefectural Okamotodai Hospital
Utsunomiya, Tochigi, Japan, 329-1104
Actively Recruiting
67
National Center of Neurology and Psychiatry
Kodaira-shi, Tokyo, Japan, 187-8551
Actively Recruiting
68
Asuka Hospital
Machida-shi, Tokyo, Japan, 194-0005
Actively Recruiting
69
Showa Medical University Karasuyama Hospital
Setagaya-ku, Tokyo, Japan, 157-8577
Actively Recruiting
70
Toyama Prefectural Center Hospital
Toyama, Toyama, Japan, 930-8550
Actively Recruiting
71
Sanyo Hospital
Sakata-shi, Yamagata, Japan, 998-0074
Actively Recruiting
72
Yamagata Sakuracho Hospital Site
Yamagata, Yamagata, Japan, 990-0045
Actively Recruiting
73
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
Research Team
O
Otsuka Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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