Clinical trial NCT05359081: A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
Official title: A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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.
2. Male or female between 18 to 65 years of age (inclusive) at the time of consent.
3. Must meet DSM 5 criteria for schizophrenia as established by clinical interview at Screening
4. Must have a PANSS total score \>=60 at Screening and Baseline.
5. Must have a CGI-S score \>=3 at Screening and Baseline
6. 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
7. 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 Criteria:

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
2. At significant risk of harming self, others, or objects based on Investigator's judgment.
3. 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.
4. Female subjects who are pregnant or lactating.
5. Have any clinically significant abnormal laboratory value(s) at Screening (hematology, chemistry, and urinalysis) as determined by the Investigator.

Primary outcomes:
measure: The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Konan-shi
country: Japan
facility: Hotei Hospital
state: Aichi
city: Akita-shi
country: Japan
facility: Heart Care Clinic Omachi
state: Akita
city: Hachinohe-shi
country: Japan
facility: Seinan Hospital
state: Aomori
city: Chiba-shi
country: Japan
facility: Ishigooka Hospital
state: Chiba
city: Ichikawa-shi
country: Japan
facility: Kohnodai Hospital National Center for Global Health and Medicine
state: Chiba
city: Fukui-shi
country: Japan
facility: Fukui Hospital
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Ai Sakura Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Inokuchi Noma Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kuramitsu Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Medical corporation Shinseikai Kaku Mental Clinic
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Mental Clinic Sakurazaka
state: Fukuoka
city: Omuta-shi
country: Japan
facility: Shiranui Hospital
state: Fukuoka
city: Aizuwakamatsu-shi
country: Japan
facility: Takeda General Hospital
state: Fukushima
city: Kiryu-shi
country: Japan
facility: Medical Corporation Kishikai Kishi Hospital
state: Gunma
city: Kure-shi
country: Japan
facility: Hayakawa Clinic
state: Hiroshima
city: Kure-shi
country: Japan
facility: NHO Kure Medical Center and Chugoku Cancer Center
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Goryokai Hospital
state: Hokkaido
city: Chuo-ku, Kobe-shi
country: Japan
facility: Tatsuta Clinic
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Kishiro Mental Clinic
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Musashikosugi J Kokorono Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Hino Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Miki Mental Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yamatenomori Kokorono Clinic
state: Kanagawa
city: Kochi-shi
country: Japan
facility: Tosa Hospital
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Kouyoudai Hospital
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Satokai Yuge Hospital
state: Kumamoto
city: Miyazaki-shi
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital
state: Miyazaki
city: Matsumoto-shi
country: Japan
facility: Ozawa Mental Clinic
state: Nagano
city: Okayama-shi
country: Japan
facility: Okayama Psychiatric Medical Center
state: Okayama
city: Kunigami-gun
country: Japan
facility: NHO Ryukyu Hospital
state: Okinawa
city: Naha-shi
country: Japan
facility: Akari Clinic
state: Okinawa
city: Naha-shi
country: Japan
facility: Miebashi Clinic
state: Okinawa
city: Urasoe-shi
country: Japan
facility: Barclay Imuro Mental Clinic
state: Okinawa
city: Urasoe-shi
country: Japan
facility: Shiroma Clinic
state: Okinawa
city: Moriguchi-shi
country: Japan
facility: Kansai Medical University Medical Center
state: Osaka
city: Moriguchi-shi
country: Japan
facility: Keihan Hospital
state: Osaka
city: Kanzaki-gun
country: Japan
facility: NHO Hizen Psychiatric Center
state: Saga
city: Karatsu-shi
country: Japan
facility: Rainbow & Sea Hospital
state: Saga
city: Tosu-shi
country: Japan
facility: Inuo Mental Care Hospital
state: Saga
city: Kumagaya-shi
country: Japan
facility: Nishi Kumagaya Hospital
state: Saitama
city: Saitama-shi
country: Japan
facility: Mental Clinic Minami
state: Saitama
city: Chiyoda-ku
country: Japan
facility: Ryokuwakai Stresscare Hibiya Clinic
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Murakami Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Narimasu Kosei Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: Senzoku Psychosomatic Medicine Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Sakura-shinmachi Mental Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Sangenjaya Neurology- Psychosomatic Clinic
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Sangubashi Kokorono Clinic
state: Tokyo
city: Toshima-ku
country: Japan
facility: Ohwa Mental Clinic
state: Tokyo
city: Sakata-shi
country: Japan
facility: Sanyo Hospital
state: Yamagata
city: Yamagata-shi
country: Japan
facility: Yamagata Sakuracho Hospital
state: Yamagata
Study officials:
References: