Long-term SEP-363856 treatment for adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial gives adult participants with DSM-5 schizophrenia daily SEP-363856 at either 75 mg or 100 mg for 52 weeks to collect long-term safety data. Eligible participants must be clinically stable for at least 8 weeks, have PANSS total ≤80 and CGI-S ≤4, and have had no recent significant antipsychotic changes. The study excludes those with recent psychiatric hospitalization, treatment-resistant illness, or prior clozapine treatment. Safety measures and clinical status will be monitored regularly at the single participating clinic in Fukuoka.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jimbo Kokorono Clinic
  Fukuoka, Japan Recruiting

Study contacts

• Study coordinator: Drug Information Center
• Phone: +81-3-6361-7314

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.