April. 25, 2022 |
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April. 12, 2024 |
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jRCT2031220039 |
A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients with Schizophrenia in Japan |
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A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients with Schizophrenia in Japan |
Yabuuchi Kazuki |
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Sumitomo Pharma Co., Ltd. |
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6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan |
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+81-120-034-389 |
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cr@sumitomo-pharma.co.jp |
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Product information center |
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Sumitomo Pharma Co., Ltd. |
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6-8, Doshomachi 2-chome, Chuo-ku, Osaka, Osaka 541-0045, Japan |
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+81-120-034-389 |
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cc@sumitomo-pharma.co.jp |
Complete |
May. 09, 2022 |
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220 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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1. 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. |
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1. 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. |
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18age old over | ||
65age old under | ||
Both |
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Schizophrenia |
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Flexible dose (50 and 75 mg/day) of SEP-363856 |
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The incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation |
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Sumitomo Pharma Co., Ltd. |
Suzuki Internal & Circulatory Medical Clinic Institutional Review Board | |
1-39-5, Sangenjaya, Setagaya-ku, Tokyo | |
+81-3-5433-3343 |
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shinkenkai.suzuki@gmail.com | |
Approval | |
No |
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NCT05359081 | |
ClinicalTrials.gov |
none |