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

Recruiting · NCT07225712 · Interventional (participants receive a specific treatment) · Lead sponsor: Otsuka Pharmaceutical Co., Ltd.

Interventions studied

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

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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)

History of psychiatric hospitalization within 8 weeks prior to screening
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)
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.

1 location listed.