A Phase 3 interventional study of SEP-363856 and Placebo in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Active, not recruiting at 73 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 3, Interventional, and Treatment
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects 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
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 538 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Participant is experiencing an acute exacerbation or relapse of symptoms, with onset ≤ 2 months prior to 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
Key Exclusion Criteria:
Placebo
Other: Placebo
SEP-363856 75 mg/day
Drug: SEP-363856
SEP-363856 100 mg/day
Drug: SEP-363856
tablet
tablet
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
Time frame: Baseline to Week 6
Clinical Global Impression-Severity (CGI-S)
Change from baseline in CGI-S score at Week 6. CGI-S is 0-7 with higher score is indicative of greater symptomatology
Time frame: Baseline to Week 6
Plan to share: Yes — 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Otsuka Pharmaceutical Development & Commercialization, Inc.