EUCTR2019-002259-40-RO进行中（未招募）1 期
A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects with Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
- •Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be = 1 year prior to Screening.
- •Subject must have a CGI-S score = 4 at Screening and Baseline.
- •Subject must have a PANSS total score = 80 at Screening and Baseline.
- •Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
- •Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
- •Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
- •Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 300
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
- •Subject has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia.
- •Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks.
- •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 C-SSRS assessment at Screening (i.e., in the past one month) or at Baseline (i.e., since last visit).
- •Subject is at significant risk of harming self or others based on Investigator’s judgment.
- •Subject has attempted suicide within 6 months prior to Screening.
- •Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer) prior to randomization or anticipates the need for psychotropic medications or herbal supplements during their participation in this study, with the exception of the medications specified in the Concomitant Medications section of this document.
- •Subject has received electroconvulsive therapy (ECT) treatment within the 3 months prior to Screening or is expected to require ECT during the study.
- •Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR.
- •Subject has 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.
- •Subject has any clinically significant abnormal laboratory value(s) at Screening.
研究者
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