EUCTR2010-020616-11-LT进行中（未招募）不适用
Phase III, multi-center, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallel group, placebo-controlled treatment period.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
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, >/= 18 years of age
- •- Diagnosis of schizophrenia
- •- Clinical stability for 16 weeks prior to randomization
- •- Antipsychotic treatment stability for 12 weeks prior to randomization
- •- With the exception of clozapine, patients are on any of the available marketed atypical or typical antipsychotic (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 540
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •- Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials
- •- Evidence that patient has clinically significant uncontrolled or unstable medical disorder (e.g. cardiovascular, renal hepatic, gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease)
- •- Patient with body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- •- Diagnosis of mental retardation or severe organic brain syndromes
- •- In the investigator's judgment, a significant risk of suicide or violent behavior
研究者
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