Schizophrenia
Conditions
Brief summary
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Interventions
DRUGSEP-363856
Tablet, once daily, for 52 weeks
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ・Incidence of treatment-emergent adverse events (TEAEs) | 52 weeks |
Countries
Japan
Contacts
Primary ContactDrug Information Center
Outcome results
None listed