Status:
TERMINATED
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.
Detailed Description
A phase 3, 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan. Participants will take flexible dose of SEP-363856 (50 mg/...
Eligibility Criteria
Inclusion
- Must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study related activities.
- Male or female between 18 to 65 years of age (inclusive) at the time of consent.
- Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
- Must have a PANSS total score \>=60 at Screening and Baseline.
- Must have a CGI-S score \>=3 at Screening and Baseline
- Judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Baseline and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening
- In the opinion of the Investigator, subjects must be generally healthy based on Screening medical history, physical examination, vital signs, ECG, and clinical laboratory values (hematology, chemistry, and urinalysis).
Exclusion
- Have a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder or substance (other than nicotine or caffeine) use disorder within past 12 months or for a total of \>= 10 years during the subject's lifetime, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms have not been a focus of primary treatment
- At significant risk of harming self, others, or objects based on Investigator's judgment.
- Have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
- Female subjects who are pregnant or lactating.
- Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.
Key Trial Info
Start Date :
May 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2024
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05359081
Start Date
May 16 2022
End Date
March 28 2024
Last Update
March 19 2025
Active Locations (51)
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1
Hotei Hospital
Konan-shi, Aichi-ken, Japan
2
Heart Care Clinic Omachi
Akita, Akita, Japan
3
Seinan Hospital
Hachinohe-shi, Aomori, Japan
4
Ishigooka Hospital
Chiba, Chiba, Japan