NCT01234779已完成2 期
A Phase II, 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 301
- 主要终点
- Safety: Incidence adverse events
研究概览
简要总结
This randomized, double-blind, placebo- and active-controlled, parallel group study will evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients, with a 4-week follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18-65 years of age
- •Diagnosis of schizophrenia (Diagnostic and Statistical Manual of Mental Disorders DSM IV-TR)
- •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
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 judged by treating physician or have failed two trials according to criteria in protocol
研究组 & 干预措施
A
Experimental
干预措施: bitopertin [RO4917838] (Drug)
B
Experimental
干预措施: bitopertin [RO4917838] (Drug)
C
Active Comparator
干预措施: olanzapine (Drug)
D
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Safety: Incidence adverse events
时间窗: 8 weeks
Change in Positive and Negative Syndrome Scale (PANSS) total score
时间窗: from baseline to Day 28
次要结局
- Global improvement as measured by the Clinical Global Impressions-Change (CGI-C) rating scale(from baseline to Day 28)
- Change in symptomatology as measured by the PANSS factor and subscale scores(from baseline to Day 28)
- Observable behavioural change as determined by the Nurses' Observation Scale For Inpatient Evaluation (NOSIE)(from baseline to Day 28)
- Clinical response, defined as at least 30% or 50% improvement from baseline PANSS total score(from baseline to Day 28)
- Global improvement as measured by the Clinical Global Impressions-Severity (CGI-S) scale(from baseline to Day 28)
- Time to readiness for discharge from inpatient unit as assessed by the Readiness For Hospital Discharge Questionnaire (RDQ)(from baseline to Day 28)
研究者
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