Recruiting NCT07225712
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SEP-363856.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
Overview
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Interventions
- Drug SEP-363856
Tablet, once daily, for 52 weeks
Primary outcome measures
- ・Incidence of treatment-emergent adverse events (TEAEs) [Time frame: 52 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Jimbo Kokorono Clinic — Fukuoka
Identifiers
NCT: NCT07225712 · 382-102-00050