A 52-week, Open-label Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Patients With Schizophrenia in Japan
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 51
- 主要终点
- The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
研究概览
简要总结
A clinical study to investigate the long-term safety and torelability of SEP-363856 in clinically stable adult patients with schizophrenia in Japan.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
SEP-363856
SEP-363856 (50 or 75 mg/day, flexible dose)
干预措施: SEP-363856 (Drug)
结局指标
主要结局
The incidence of overall adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
时间窗: 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.
次要结局
未报告次要终点