NCT01192906已完成3 期
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.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 624
- 主要终点
- Efficacy (PANSS negative symptoms factor score)
研究概览
简要总结
This multi-center, randomized, double blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with persistent, predominant negative symptoms of schizophrenia. Patients, on stable treatment with antipsychotics, will be randomized to receive daily oral doses of RO4917838 or matching placebo for 52 weeks, followed by an optional treatment extension for up to 3 years.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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)
排除标准
- •Evidence that patient has clinically significant, uncontrolled and unstable disorder (e.g. cardiovascular, renal, hepatic disorder)
- •Body Mass Index (BMI) of <17 or >40 kg/m2
- •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 Parkinsonism item of the ESRS-A (Clinical Global Impression, Parkinsonism)
研究组 & 干预措施
1
Experimental
干预措施: bitopertin [RO4917838] (Drug)
2
Experimental
干预措施: bitopertin [RO4917838] (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy (PANSS negative symptoms factor score)
时间窗: Week 24
Safety (incidence of adverse events)
时间窗: Week 24
次要结局
未报告次要终点
研究者
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