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ZYPREXA?
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- F. Hoffmann-La Roche Ltd
- 入组人数
- 380
- 状态
- 进行中（未招募）
- 最后更新
- 9年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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