A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
- Registration Number
- NCT05359081
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- 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/day and 75 mg/day) every night at bedtime for 52 weeks in an open-label manner.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 68
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SEP-363856 SEP-363856 SEP-363856 (50 or 75 mg/day, flexible dose)
- Primary Outcome Measures
Name Time Method The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. Week 52 Evaluate the long-term safety and tolerability of flexible dosed SEP-363856 (50 and 75 mg/day) in subjects with schizophrenia by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (51)
Sangubashi Kokorono Clinic
🇯🇵Shibuya-ku, Tokyo, Japan
Ryokuwakai Stresscare Hibiya Clinic
🇯🇵Chiyoda-ku, Tokyo, Japan
Kuramitsu Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hayakawa Clinic
🇯🇵Kure-shi, Hiroshima, Japan
Musashikosugi J Kokorono Clinic
🇯🇵Kawasaki-shi, Kanagawa, Japan
Miki Mental Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
Ishigooka Hospital
🇯🇵Chiba-shi, Chiba, Japan
Medical Corporation Kishikai Kishi Hospital
🇯🇵Kiryu-shi, Gunma, Japan
Kishiro Mental Clinic
🇯🇵Kawasaki-shi, Kanagawa, Japan
Seinan Hospital
🇯🇵Hachinohe-shi, Aomori, Japan
Fukui Hospital
🇯🇵Fukui-shi, Fukui, Japan
Tosa Hospital
🇯🇵Kochi-shi, Kochi, Japan
Mental Clinic Sakurazaka
🇯🇵Fukuoka-shi, Fukuoka, Japan
NHO Ryukyu Hospital
🇯🇵Kunigami-gun, Okinawa, Japan
Kouyoudai Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Hino Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
Kansai Medical University Medical Center
🇯🇵Moriguchi-shi, Osaka, Japan
Satokai Yuge Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Ozawa Mental Clinic
🇯🇵Matsumoto-shi, Nagano, Japan
Akari Clinic
🇯🇵Naha-shi, Okinawa, Japan
Miebashi Clinic
🇯🇵Naha-shi, Okinawa, Japan
Barclay Imuro Mental Clinic
🇯🇵Urasoe-shi, Okinawa, Japan
Keihan Hospital
🇯🇵Moriguchi-shi, Osaka, Japan
Inuo Mental Care Hospital
🇯🇵Tosu-shi, Saga, Japan
Mental Clinic Minami
🇯🇵Saitama-shi, Saitama, Japan
Yamagata Sakuracho Hospital
🇯🇵Yamagata-shi, Yamagata, Japan
Hotei Hospital
🇯🇵Konan-shi, Aichi, Japan
Kohnodai Hospital National Center for Global Health and Medicine
🇯🇵Ichikawa-shi, Chiba, Japan
Heart Care Clinic Omachi
🇯🇵Akita-shi, Akita, Japan
Ai Sakura Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Inokuchi Noma Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Takeda General Hospital
🇯🇵Aizuwakamatsu-shi, Fukushima, Japan
Medical corporation Shinseikai Kaku Mental Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
NHO Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure-shi, Hiroshima, Japan
Shiranui Hospital
🇯🇵Omuta-shi, Fukuoka, Japan
Goryokai Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Tatsuta Clinic
🇯🇵Chuo-ku, Kobe-shi, Hyogo, Japan
Miyazaki Prefectural Miyazaki Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Yamatenomori Kokorono Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
Okayama Psychiatric Medical Center
🇯🇵Okayama-shi, Okayama, Japan
Shiroma Clinic
🇯🇵Urasoe-shi, Okinawa, Japan
NHO Hizen Psychiatric Center
🇯🇵Kanzaki-gun, Saga, Japan
Nishi Kumagaya Hospital
🇯🇵Kumagaya-shi, Saitama, Japan
Rainbow & Sea Hospital
🇯🇵Karatsu-shi, Saga, Japan
Senzoku Psychosomatic Medicine Clinic
🇯🇵Meguro-ku, Tokyo, Japan
Murakami Hospital
🇯🇵Edogawa-ku, Tokyo, Japan
Ohwa Mental Clinic
🇯🇵Toshima-ku, Tokyo, Japan
Sanyo Hospital
🇯🇵Sakata-shi, Yamagata, Japan
Narimasu Kosei Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
Sakura-shinmachi Mental Clinic
🇯🇵Setagaya-ku, Tokyo, Japan
Sangenjaya Neurology- Psychosomatic Clinic
🇯🇵Setagaya-ku, Tokyo, Japan