A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Japan
Jimbo Kokorono Clinic
RECRUITING
Fukuoka
Contact Information
Primary
Drug Information Center
+81-3-6361-7314
Time Frame
Start Date: 2025-12-22
Estimated Completion Date: 2028-03
Participants
Target number of participants: 100
Treatments
Experimental: SEP-363856 75 or 100 mg/day (dose selected per protocol)
SEP-363856 will be administered at 50 mg/day from Day 1 to Day 3, and 75 mg/day from Day 4 to Day 7. From Day 8 onward, the dose will, in principle, be 100 mg/day unless there are tolerability concerns; however, in accordance with protocol, the investigator or sub-investigator may select either 75 mg/day or 100 mg/day.
Related Therapeutic Areas
Sponsors
Leads: Otsuka Pharmaceutical Co., Ltd.