Actively Recruiting
A Multicenter, Open-label Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Adults With Schizophrenia
Led by Otsuka Pharmaceutical Co., Ltd. · Updated on 2026-01-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of a drug called SEP-363856 in adults diagnosed with schizophrenia. The study aims to understand how well patients tolerate the medication when taken daily for up to 52 weeks. This research is a phase 3 trial led by Otsuka Pharmaceutical Co., Ltd., focusing on long-term treatment effects in clinically stable individuals with this condition. Participants will take SEP-363856 tablets once daily, starting with 50 mg per day for the first three days, increasing to 75 mg per day for days four to seven. From day eight onwards, the dose will typically be 100 mg per day unless there are concerns about tolerability, in which case the dose may be adjusted to 75 mg. The study does not include a comparison group and all participants receive the investigational medication. During the 52-week treatment period, researchers will monitor participants closely for any adverse events and measure how often these treatment-emergent side effects occur. Participants will have regular assessments to ensure clinical stability, including evaluations of symptoms and medication adherence. The study provides ongoing safety monitoring throughout the year-long participation.
CONDITIONS
Brief 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
- Clinically stable for at least 8 weeks prior to 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 (minor dose adjustments allowed)
You will not qualify if you...
- Psychiatric hospitalization within 8 weeks prior to screening
- Treatment-resistant to antipsychotic therapy within 1 year before screening
- History of treatment with clozapine
- Unwillingness to comply with protocol medication and therapy requirements or use of prohibited medications at screening or baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 52 weeks
Participants take SEP-363856 tablets once daily with dose adjustments per protocol for up to 52 weeks.
Daily dosing with regular visits as determined by the study team
Trial Site Locations
Total: 1 location
1
Jimbo Kokorono Clinic
Fukuoka, Japan
Actively Recruiting
Research Team
D
Drug Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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