NCT07225712招募中3 期
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- ・ Incidence of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male or female participants 18 years of age or older at the time of informed consent
- •Diagnosed with schizophrenia according to the DSM-5®
- •Judged by the investigator to be clinically stable for at least 8 weeks prior to screening
- •PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline
- •No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)
排除标准
- •History of psychiatric hospitalization within 8 weeks prior to screening
- •Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks [28 consecutive days] in accordance with the package insert, psychiatric symptoms did not improve)
- •History of treatment with clozapine
- •Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.
研究组 & 干预措施
SEP-363856 75 or 100 mg/day (dose selected per protocol)
Experimental
SEP-363856 will be administered at 50 mg/day from Day 1 to Day 3, and 75 mg/day from Day 4 to Day 7. From Day 8 onward, the dose will, in principle, be 100 mg/day unless there are tolerability concerns; however, in accordance with protocol, the investigator or sub-investigator may select either 75 mg/day or 100 mg/day.
干预措施: SEP-363856 (Drug)
结局指标
主要结局
・ Incidence of treatment-emergent adverse events (TEAEs)
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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