RecruitingPhase 3NCT07225712

A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia

A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia


Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

100 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a long-term use of a medication called SEP-363856 (also known as ulotaront) in Japanese people with schizophrenia. Researchers want to see if the drug is safe and effective when taken over a longer period of time. **You may be eligible if...** - You are Japanese, age 18 or older - You have been diagnosed with schizophrenia - Your symptoms have been stable for at least 8 weeks - Your symptom scores are at a mild-to-moderate level (PANSS ≤ 80, CGI-S ≤ 4) - Your antipsychotic medication has not changed in the past 6 weeks **You may NOT be eligible if...** - You were hospitalized for psychiatric reasons in the past 8 weeks - You have tried two or more antipsychotic medications without improvement - You have ever been treated with clozapine - You are unwilling to follow the medication rules in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSEP-363856

Tablet, once daily, for 52 weeks


Locations(1)

Jimbo Kokorono Clinic

Fukuoka, Japan

View Full Details on ClinicalTrials.gov

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NCT07225712


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