EUCTR2010-020470-42-CZ进行中（未招募）不适用
A Phase III, multi-center, randomized, 24 week, double-blind, parallel-group, placebo-controlled study to evaluate efficacy and safety of RO4917838 in stable patients with persistent, predominant negative symptoms of schizophrenia treated with antipsychotics followed by a 28 week double-blind treatment period.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 630
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
- •Adult patients, aged 18 years and above
- •Diagnosis of schizophrenia of paranoid, disorganized, residual, undifferentiated or catatonic subtype
- •Predominant negative symptoms
- •With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotics (treatment with a maximum of two antipsychotics)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- •Patient with body mass index (BMI) < 17 kg/m2 or > 40
- •Depressive symptoms, defined as a score of 9 or greater on the Calgary Depression Rating Scale for Schizophrenia (CDSS)
- •A severity score of 3 or greater on the global Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism).
研究者
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