๐ฌIn plain words
What the trial is, and whether it could suit you
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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-5ยฎ
* 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.
Jimbo Kokorono Clinic
Fukuoka, Japan
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.