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

JRCT ID: jRCT2031220039

Registered date:25/04/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Schizophrenia
• Date of first enrollment: 09/05/2022
• Target sample size: 220
• Study type: Interventional
• Intervention(s): Flexible dose (50 and 75 mg/day) of SEP-363856

Outcome(s)

• Primary Outcome: The incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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).

Exclude 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.

Related Information

• Primary Sponsor: Yabuuchi Kazuki
• Secondary ID(s): NCT05359081