CTIS2024-513194-44-00进行中（未招募）1 期
A 6-week, International, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 years of age) with Schizophrenia - RGH-MD-20
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 257
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Inpatients or outpatients, 13 to 17 years of age, inclusive, at the time of obtaining the informed consent and assent, DSM-5 primary diagnosis of schizophrenia, Schizophrenia diagnosis confirmed by the K-SADS-PL administered at screening (Visit 1) by a trained clinician., PANSS score = 70 and a score of = 4 (moderate) on 2 or more of the 5 items on the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution), at screening (Visit 1) and baseline (Visit 2)., CGI-S scale score of = 4 (moderately ill) at screening (Visit 1) and baseline (Visit 2)
排除标准
- •Current diagnosis of bipolar disorder, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, or psychotic disorder due to another medical condition, Diagnosis of intellectual disability (IQ < 70), Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Visit 1.
研究者
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