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Ulotaront (SEP-363856) for Schizophrenia

This study is testing a drug called Ulotaront (SEP-363856) to see if it is safe and effective for people with schizophrenia who are currently experiencing an acute (sudden and severe) worsening of their symptoms. You might be able to join if you are between 18 and 65 years old, have a reliable person who can provide information about you (like a family member or friend), and have had a recent increase in your schizophrenia symptoms within the last two months. The main way we'll know if the treatment is working is by measuring changes in your symptoms using a tool called the Positive And Negative Syndrome Scale (PANSS) over six weeks. The study is currently not specified as recruiting or not recruiting.

Study design
This is a Phase 3, randomized, double-blind study, meaning some participants will receive Ulotaront (SEP-363856) and others will receive a placebo (an inactive tablet), and neither you nor your doctor will know which you are getting. About 522 people are planned to join this study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be followed for six weeks after starting treatment to see how the drug affects you.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06894212

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Otsuka Pharmaceutical Development & Commercialization, Inc.
~522 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:SEP-363856Placebo

At a glance

Recruiting sites
38 of 73 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6
Measured over Baseline to Week 6

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

73 sites across 29 states
California10
Florida7
Arkansas4
Georgia4
Texas4
Fukuoka4
Kanagawa4
Hokkaido3

Who to contact

Otsuka Call Center
[email protected]
844-687-8522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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:
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.

Exclusion

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

What this trial measures

  • The change from baseline in Positive And Negative Syndrome Scale (PANSS) total score at Week 6Baseline to 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