Trials / Recruiting
RecruitingNCT07225712
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SEP-363856 | Tablet, once daily, for 52 weeks |
Timeline
- Start date
- 2025-12-22
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2025-11-10
- Last updated
- 2026-01-14
Locations
1 site across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07225712. Inclusion in this directory is not an endorsement.