EUCTR2010-021984-33-SK进行中（未招募）1 期
A phase II/III, multi-center, randomized, 4-week, double-blind, parallel group, placebo and active-controlled trial of the safety and efficacy of RO4917838 vs. placebo in patients with an acute exacerbation of schizophrenia. - Candlelyte
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 380
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, 18-65 years of age
- •? Acute exacerbation which began within the prior 8 weeks
- •? Female patients must be surgically sterile or post-menopausal, or agree to use effective contraception for the duration of the study
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •? Current psychiatric diagnosis other than schizophrenia
- •alcohol or substance dependence within 3 months or abuse within 1 month (except for nicotine)
- •? Electro-convulsive therapy (ECT) within the prior 6 months
- •? Previous treatment with RO4917838 or another GLYT inhibitor
- •? Current treatment with olanzapine, or previous treatment with intolerability or lack of response
- •? Treatment with long-acting injectable antipsychotic within 2 dosing intervals
- •? Treatment with > 2 antipsychotics within 3 months
- •? History of neuroleptic malignant syndrome
- •? Have treatment resistant schizophrenia as judge by the treating physician OR have failed two trials.
研究者
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