EUCTR2018-004006-26-BG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
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
- 330
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
- •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).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 330
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 substancerelated disorder (except caffeine- and tobacco-related) within the 3 months
- •before Visit 1.
研究者
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