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TerminatedPhase 3

A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan

Reason given: 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, and Yokohama, JapanSee the 51 sites
Phase
Phase 3

Where in Japan

  • Takeda General HospitalAizuwakamatsu-shi, JapanNo longer taking part
  • Heart Care Clinic OmachiAkita, JapanNo longer taking part
  • Ishigooka HospitalChiba, JapanNo longer taking part
  • Ryokuwakai Stresscare Hibiya ClinicChiyoda-ku, JapanNo longer taking part
  • Tatsuta ClinicChuo-ku, Kobe-shi, JapanNo longer taking part
  • Murakami HospitalEdogawa-ku, JapanNo longer taking part
  • Fukui HospitalFukui-shi, JapanNo longer taking part
  • Ai Sakura ClinicFukuoka, JapanNo longer taking part
  • Inokuchi Noma HospitalFukuoka, JapanNo longer taking part
  • Kuramitsu HospitalFukuoka, JapanNo longer taking part
  • Medical corporation Shinseikai Kaku Mental ClinicFukuoka, JapanNo longer taking part
  • Mental Clinic SakurazakaFukuoka, JapanNo longer taking part
  • Seinan HospitalHachinohe-shi, JapanNo longer taking part
  • Kohnodai Hospital National Center for Global Health and MedicineIchikawa-shi, JapanNo longer taking part
  • NHO Hizen Psychiatric CenterKanzaki-gun, JapanNo longer taking part
  • Rainbow & Sea HospitalKaratsu-shi, JapanNo longer taking part
  • Kishiro Mental ClinicKawasaki-shi, JapanNo longer taking part
  • Musashikosugi J Kokorono ClinicKawasaki-shi, JapanNo longer taking part
  • Medical Corporation Kishikai Kishi HospitalKiryu-shi, JapanNo longer taking part
  • Tosa HospitalKochi, JapanNo longer taking part
  • Hotei HospitalKonan-shi, JapanNo longer taking part
  • Nishi Kumagaya HospitalKumagaya-shi, JapanNo longer taking part
  • Kouyoudai HospitalKumamoto, JapanNo longer taking part
  • Satokai Yuge HospitalKumamoto, JapanNo longer taking part
  • NHO Ryukyu HospitalKunigami-gun, JapanNo longer taking part
  • NHO Kure Medical Center and Chugoku Cancer CenterKure Shi, JapanNo longer taking part
  • Hayakawa ClinicKure-shi, JapanNo longer taking part
  • Ozawa Mental ClinicMatsumoto-shi, JapanNo longer taking part
  • Senzoku Psychosomatic Medicine ClinicMeguro-ku, JapanNo longer taking part
  • Miyazaki Prefectural Miyazaki HospitalMiyazaki, JapanNo longer taking part
  • Kansai Medical University Medical CenterMoriguchi-shi, JapanNo longer taking part
  • Keihan HospitalMoriguchi-shi, JapanNo longer taking part
  • Akari ClinicNaha, JapanNo longer taking part
  • Miebashi ClinicNaha, JapanNo longer taking part
  • Okayama Psychiatric Medical CenterOkayama, JapanNo longer taking part
  • Shiranui HospitalOmuta-shi, JapanNo longer taking part
  • Mental Clinic MinamiSaitama-shi, JapanNo longer taking part
  • Sanyo HospitalSakata-shi, JapanNo longer taking part
  • Goryokai HospitalSapporo, JapanNo longer taking part
  • Sakura-shinmachi Mental ClinicSetagaya-ku, JapanNo longer taking part
  • Sangenjaya Neurology- Psychosomatic ClinicSetagaya-ku, JapanNo longer taking part
  • Sangubashi Kokorono ClinicShibuya-ku, JapanNo longer taking part
  • Narimasu Kosei Hospitaltabashi City, JapanNo longer taking part
  • Ohwa Mental ClinicToshima-ku, JapanNo longer taking part
  • Inuo Mental Care HospitalTosu-shi, JapanNo longer taking part
  • Barclay Imuro Mental ClinicUrasoe-shi, JapanNo longer taking part
  • Shiroma ClinicUrasoe-shi, JapanNo longer taking part
  • Yamagata Sakuracho HospitalYamagata, JapanNo longer taking part
  • Hino HospitalYokohama, JapanNo longer taking part
  • Miki Mental ClinicYokohama, JapanNo longer taking part
  • Yamatenomori Kokorono ClinicYokohama, JapanNo longer taking part

Trial details

Who runs it
Sumitomo Pharma Co., Ltd.
Trial code
NCT05359081
Record updated
19 March 2025
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.

ClinicalTrials.gov NCT05359081