NCT07225712 A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
| NCT ID | NCT07225712 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 100 participants in total. It began in 2025-12-22 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Drug Information Center
📞 +81-3-6361-7314
Nobuhito Sanada
STUDY DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Frequently Asked Questions
Who can join the NCT07225712 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225712 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 100 participants.
Is NCT07225712 currently recruiting?
Yes, NCT07225712 is actively recruiting participants. Visit ClinicalTrials.gov or contact Otsuka Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT07225712 trial being conducted?
This trial is being conducted at Fukuoka, Japan.
Who is sponsoring the NCT07225712 clinical trial?
NCT07225712 is sponsored by Otsuka Pharmaceutical Co., Ltd.. The principal investigator is Nobuhito Sanada at Otsuka Pharmaceutical Co., Ltd.. The trial plans to enroll 100 participants.
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