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Testing SEP-363856 for treating acute psychosis in 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

Phase 3 Interventional Otsuka Pharmaceutical Development & Commercialization, Inc. · NCT06894212

This study is testing a new medication called SEP-363856 to see if it can help people with schizophrenia who are experiencing severe psychosis and need to be hospitalized.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment522 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc. Industry-sponsored
Locations73 sites (Bentonville, Arkansas and 72 other locations)
Trial IDNCT06894212 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial evaluates the efficacy and safety of SEP-363856 in participants experiencing acute psychosis due to schizophrenia. It is a multicenter, randomized, double-blind, placebo-controlled trial, meaning that participants will be randomly assigned to receive either the investigational drug or a placebo without knowing which one they are receiving. The study aims to assess the impact of SEP-363856 on symptoms of schizophrenia in individuals who require hospitalization due to an acute exacerbation of their condition.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who are experiencing an acute exacerbation of schizophrenia symptoms and require hospitalization.

Not a fit: Patients who are not experiencing an acute exacerbation of symptoms or those who have been hospitalized for more than two weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from acute psychosis associated with schizophrenia.

How similar studies have performed: Other studies have explored novel treatments for schizophrenia, but the specific approach of SEP-363856 is relatively novel and has not been extensively tested in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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

  1. The participant requires hospitalization for this acute exacerbation or relapse of symptoms.
  2. 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:

  1. Participant must have a PANSS total score ≥ 80

     AND
  2. 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.

Key Exclusion Criteria:

* 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

Where this trial is running

Bentonville, Arkansas and 72 other locations

+23 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.