Long-term Study of SEP-363856 in People With Schizophrenia
Tests SEP-363856 over 52 weeks in adults with schizophrenia, focusing on safety.
Plain-language title generated from the registry record
Registry title: A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
Key facts
- Where
- Fukuoka, JapanSee the site
- Phase
- Phase 3
Where in Japan
- Jimbo Kokorono ClinicFukuoka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Otsuka Pharmaceutical Co., Ltd.
- Trial code
- NCT07225712
- Record updated
- 14 January 2026
- Original description
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophreniaRead full original descriptionShow less
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Inclusion: Japanese male or female participants 18 years of age or older at the time of informed consent; Diagnosed with schizophrenia according to the DSM-5®; Judged by the investigator to be clinically stable for at least 8 weeks prior to screening; PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline; No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability).
Exclusion: History of psychiatric hospitalization within 8 weeks prior to screening; History of treatment with clozapine; Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol; Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks [28 consecutive days] in accordance with the package insert, psychiatric symptoms did not improve).