NCT05848700已完成1 期
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.7 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period
研究概览
简要总结
A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia. This study will be held in approximately 6 study sites in the United States. It will be accepting male and female participants age 18 years to 65 years. Participation will be up to approximately10 weeks.
详细描述
This is a double-blind, placebo-controlled, randomized withdrawal study comparing abrupt discontinuation of SEP-363856 (SEP-363856 switched to placebo) to continuous SEP-363856 treatment in male and female adult subjects with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blind
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
- •(this list is not all inclusive)
- •Male or female subject between 18 and 65 years of age (inclusive) at the time of informed consent.
- •Subject meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a primary diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the Structured Clinical Interview for DSM-5, Clinical Trials Version [SCID-CT]).
- •Subject must have a Clinical Global Impression-Severity Scale (CGI-S) score ≤ 4 (normal to moderately ill) at Screening and Day
- •Subject must have a PANSS total score ≤ 80 at Screening and a score of ≤ 4 on the following PANSS items at Screening: P7 (hostility) and G8 (uncooperativeness).
- •Subject has been taking an antipsychotic for at least 6 weeks prior to Screening and has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes may be permitted) for at least 6 weeks prior to Screening.
排除标准
- •(this list is not all inclusive)
- •Subject has a DSM-5 diagnosis or presence of symptoms consistent with a current DSM-5 diagnosis other than schizophrenia.
- •Subject has attempted suicide within 6 months prior to Screening.
- •Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening (ie, in the past 1 month) or at any subsequent C-SSRS assessment prior to dosing (ie, since last visit).
- •Subject is at significant risk of harming him/herself or others (passive or active) according to the Investigator's judgment.
研究组 & 干预措施
SEP-363856
Experimental
干预措施: SEP-363856 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum change from the steady-state baseline (CSSBmax) in the total score of the 20 item Physician Withdrawal Checklist (PWC-20) during the 7-day Randomized Withdrawal Period
时间窗: up to10 weeks
次要结局
未报告次要终点
研究者
研究点 (7)
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