A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
Megadott ok: Due to company business strategy
Key facts
- Where
- Aizuwakamatsu-shi, Akita, Chiba, Chiyoda-ku, Chuo-ku, Kobe-shi, Edogawa-ku, Fukui-shi, Fukuoka, Hachinohe-shi, Ichikawa-shi, Kanzaki-gun, Karatsu-shi, Kawasaki-shi, Kiryu-shi, Kochi, Konan-shi, Kumagaya-shi, Kumamoto, Kunigami-gun, Kure Shi, Kure-shi, Matsumoto-shi, Meguro-ku, Miyazaki, Moriguchi-shi, Naha, Okayama, Omuta-shi, Saitama-shi, Sakata-shi, Sapporo, Setagaya-ku, Shibuya-ku, tabashi City, Toshima-ku, Tosu-shi, Urasoe-shi, Yamagata és Yokohama, JapánSee the 51 sites
- Phase
- 3. fázis
Where in Japán
- Takeda General HospitalAizuwakamatsu-shi, JapánNo longer taking part
- Heart Care Clinic OmachiAkita, JapánNo longer taking part
- Ishigooka HospitalChiba, JapánNo longer taking part
- Ryokuwakai Stresscare Hibiya ClinicChiyoda-ku, JapánNo longer taking part
- Tatsuta ClinicChuo-ku, Kobe-shi, JapánNo longer taking part
- Murakami HospitalEdogawa-ku, JapánNo longer taking part
- Fukui HospitalFukui-shi, JapánNo longer taking part
- Ai Sakura ClinicFukuoka, JapánNo longer taking part
- Inokuchi Noma HospitalFukuoka, JapánNo longer taking part
- Kuramitsu HospitalFukuoka, JapánNo longer taking part
- Medical corporation Shinseikai Kaku Mental ClinicFukuoka, JapánNo longer taking part
- Mental Clinic SakurazakaFukuoka, JapánNo longer taking part
- Seinan HospitalHachinohe-shi, JapánNo longer taking part
- Kohnodai Hospital National Center for Global Health and MedicineIchikawa-shi, JapánNo longer taking part
- NHO Hizen Psychiatric CenterKanzaki-gun, JapánNo longer taking part
- Rainbow & Sea HospitalKaratsu-shi, JapánNo longer taking part
- Kishiro Mental ClinicKawasaki-shi, JapánNo longer taking part
- Musashikosugi J Kokorono ClinicKawasaki-shi, JapánNo longer taking part
- Medical Corporation Kishikai Kishi HospitalKiryu-shi, JapánNo longer taking part
- Tosa HospitalKochi, JapánNo longer taking part
- Hotei HospitalKonan-shi, JapánNo longer taking part
- Nishi Kumagaya HospitalKumagaya-shi, JapánNo longer taking part
- Kouyoudai HospitalKumamoto, JapánNo longer taking part
- Satokai Yuge HospitalKumamoto, JapánNo longer taking part
- NHO Ryukyu HospitalKunigami-gun, JapánNo longer taking part
- NHO Kure Medical Center and Chugoku Cancer CenterKure Shi, JapánNo longer taking part
- Hayakawa ClinicKure-shi, JapánNo longer taking part
- Ozawa Mental ClinicMatsumoto-shi, JapánNo longer taking part
- Senzoku Psychosomatic Medicine ClinicMeguro-ku, JapánNo longer taking part
- Miyazaki Prefectural Miyazaki HospitalMiyazaki, JapánNo longer taking part
- Kansai Medical University Medical CenterMoriguchi-shi, JapánNo longer taking part
- Keihan HospitalMoriguchi-shi, JapánNo longer taking part
- Akari ClinicNaha, JapánNo longer taking part
- Miebashi ClinicNaha, JapánNo longer taking part
- Okayama Psychiatric Medical CenterOkayama, JapánNo longer taking part
- Shiranui HospitalOmuta-shi, JapánNo longer taking part
- Mental Clinic MinamiSaitama-shi, JapánNo longer taking part
- Sanyo HospitalSakata-shi, JapánNo longer taking part
- Goryokai HospitalSapporo, JapánNo longer taking part
- Sakura-shinmachi Mental ClinicSetagaya-ku, JapánNo longer taking part
- Sangenjaya Neurology- Psychosomatic ClinicSetagaya-ku, JapánNo longer taking part
- Sangubashi Kokorono ClinicShibuya-ku, JapánNo longer taking part
- Narimasu Kosei Hospitaltabashi City, JapánNo longer taking part
- Ohwa Mental ClinicToshima-ku, JapánNo longer taking part
- Inuo Mental Care HospitalTosu-shi, JapánNo longer taking part
- Barclay Imuro Mental ClinicUrasoe-shi, JapánNo longer taking part
- Shiroma ClinicUrasoe-shi, JapánNo longer taking part
- Yamagata Sakuracho HospitalYamagata, JapánNo longer taking part
- Hino HospitalYokohama, JapánNo longer taking part
- Miki Mental ClinicYokohama, JapánNo longer taking part
- Yamatenomori Kokorono ClinicYokohama, JapánNo longer taking part
Trial details
- Who runs it
- Sumitomo Pharma Co., Ltd.
- Trial code
- NCT05359081
- Record updated
- 2025. március 19.
- Original description
A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.Read full original descriptionShow less
A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.
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 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; Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator; 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; Female subjects who are pregnant or lactating.