Study Stopped
Due to company business strategy
A Clinical Trial to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
1 other identifier
interventional
68
1 country
51
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started May 2022
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2022
CompletedFirst Posted
Study publicly available on registry
May 3, 2022
CompletedStudy Start
First participant enrolled
May 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2024
CompletedMarch 19, 2025
April 1, 2024
1.8 years
April 27, 2022
March 16, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
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.
Week 52
Study Arms (1)
SEP-363856
EXPERIMENTALSEP-363856 (50 or 75 mg/day, flexible dose)
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
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
Related Publications (1)
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.
PMID: 36369028DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2022
First Posted
May 3, 2022
Study Start
May 16, 2022
Primary Completion
March 21, 2024
Study Completion
March 28, 2024
Last Updated
March 19, 2025
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share