A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
NCT ID: NCT07225712
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2025-12-31
2028-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
SEP-363856
Tablet, once daily, for 52 weeks
Interventions
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SEP-363856
Tablet, once daily, for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Nobuhito Sanada
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
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Jimbo Kokorono Clinic
Fukuoka, , Japan
Countries
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Central Contacts
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Drug Information Center
Role: CONTACT
Phone: +81-3-6361-7314
Other Identifiers
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382-102-00050
Identifier Type: -
Identifier Source: org_study_id