Actively Recruiting
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
CONDITIONS
Official Title
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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�ae
- Clinically stable for at least 8 weeks before screening
- PANSS total score of 80 or less and CGI-S score of 4 or less at screening and baseline
- No changes in antipsychotic medication for at least 6 weeks before screening (except minor dose adjustments for tolerability)
You will not qualify if you...
- History of psychiatric hospitalization within 8 weeks prior to screening
- Treatment-resistant to antipsychotic therapy within 1 year before screening despite adequate doses of two or more antipsychotics for at least 4 weeks
- History of treatment with clozapine
- Unwillingness to comply with medication and therapy requirements during the trial or use of prohibited medications at screening or baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Jimbo Kokorono Clinic
Fukuoka, Japan
Actively Recruiting
Research Team
D
Drug Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here