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

NCT ID: NCT05359081

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2024-03-28

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEP-363856

SEP-363856 (50 or 75 mg/day, flexible dose)

Group Type: EXPERIMENTAL

SEP-363856

Intervention Type: DRUG

SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Interventions

SEP-363856

SEP-363856 50 mg or 75 mg, flexibly dosed once daily tablet for 52 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hotei Hospital

Konan-shi, Aichi-ken, Japan

Heart Care Clinic Omachi

Akita, Akita, Japan

Seinan Hospital

Hachinohe-shi, Aomori, Japan

Ishigooka Hospital

Chiba, Chiba, Japan

Kohnodai Hospital National Center for Global Health and Medicine

Ichikawa-shi, Chiba, Japan

Fukui Hospital

Fukui-shi, Fukui, Japan

Ai Sakura Clinic

Fukuoka, Fukuoka, Japan

Inokuchi Noma Hospital

Fukuoka, Fukuoka, Japan

Kuramitsu Hospital

Fukuoka, Fukuoka, Japan

Medical corporation Shinseikai Kaku Mental Clinic

Fukuoka, Fukuoka, Japan

Mental Clinic Sakurazaka

Fukuoka, Fukuoka, Japan

Shiranui Hospital

Omuta-shi, Fukuoka, Japan

Takeda General Hospital

Aizuwakamatsu-shi, Fukushima, Japan

Medical Corporation Kishikai Kishi Hospital

Kiryu-shi, Gunma, Japan

Hayakawa Clinic

Kure-shi, Hiroshima, Japan

NHO Kure Medical Center and Chugoku Cancer Center

Kure-shi, Hiroshima, Japan

Goryokai Hospital

Sapporo, Hokkaido, Japan

Tatsuta Clinic

Chuo-ku, Kobe-shi, Hyōgo, Japan

Kishiro Mental Clinic

Kawasaki-shi, Kanagawa, Japan

Musashikosugi J Kokorono Clinic

Kawasaki-shi, Kanagawa, Japan

Hino Hospital

Yokohama, Kanagawa, Japan

Miki Mental Clinic

Yokohama, Kanagawa, Japan

Yamatenomori Kokorono Clinic

Yokohama, Kanagawa, Japan

Tosa Hospital

Kochi, Kochi, Japan

Kouyoudai Hospital

Kumamoto, Kumamoto, Japan

Satokai Yuge Hospital

Kumamoto, Kumamoto, Japan

Miyazaki Prefectural Miyazaki Hospital

Miyazaki, Miyazaki, Japan

Ozawa Mental Clinic

Matsumoto-shi, Nagano, Japan

Okayama Psychiatric Medical Center

Okayama, Okayama-ken, Japan

NHO Ryukyu Hospital

Kunigami-gun, Okinawa, Japan

Akari Clinic

Naha, Okinawa, Japan

Miebashi Clinic

Naha, Okinawa, Japan

Barclay Imuro Mental Clinic

Urasoe-shi, Okinawa, Japan

Shiroma Clinic

Urasoe-shi, Okinawa, Japan

Kansai Medical University Medical Center

Moriguchi-shi, Osaka, Japan

Keihan Hospital

Moriguchi-shi, Osaka, Japan

NHO Hizen Psychiatric Center

Kanzaki-gun, Saga-ken, Japan

Rainbow & Sea Hospital

Karatsu-shi, Saga-ken, Japan

Inuo Mental Care Hospital

Tosu-shi, Saga-ken, Japan

Nishi Kumagaya Hospital

Kumagaya-shi, Saitama, Japan

Mental Clinic Minami

Saitama-shi, Saitama, Japan

Ryokuwakai Stresscare Hibiya Clinic

Chiyoda-ku, Tokyo, Japan

Murakami Hospital

Edogawa-ku, Tokyo, Japan

Narimasu Kosei Hospital

Itabashi-ku, Tokyo, Japan

Senzoku Psychosomatic Medicine Clinic

Meguro-ku, Tokyo, Japan

Sakura-shinmachi Mental Clinic

Setagaya-ku, Tokyo, Japan

Sangenjaya Neurology- Psychosomatic Clinic

Setagaya-ku, Tokyo, Japan

Sangubashi Kokorono Clinic

Shibuya-ku, Tokyo, Japan

Ohwa Mental Clinic

Toshima-ku, Tokyo, Japan

Sanyo Hospital

Sakata-shi, Yamagata, Japan

Yamagata Sakuracho Hospital

Yamagata, Yamagata, Japan

Countries

Japan

References

Halff EF, Rutigliano G, Garcia-Hidalgo A, Howes OD. Trace amine-associated receptor 1 (TAAR1) agonism as a new treatment strategy for schizophrenia and related disorders. Trends Neurosci. 2023 Jan;46(1):60-74. doi: 10.1016/j.tins.2022.10.010. Epub 2022 Nov 8.

Reference Type: DERIVED

PMID: 36369028 (View on PubMed)

Other Identifiers

DA801202

Identifier Type: -

Identifier Source: org_study_id