NCT01235559已完成3 期
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.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 604
- 主要终点
- Safety (incidence of adverse events)
研究概览
简要总结
This randomized, multi-center double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4917838 (bitopertin) in patients with sub-optimally controlled 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, >/= 18 years of age
- •Diagnosis of schizophrenia
- •Clinical stability for 16 weeks (4 months) prior to randomization
- •Antipsychotic treatment stability for the past 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)
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 has a body mass index (BMI) of <17 or >40 kg/m2, respectively)
- •Diagnosis of mental retardation or severe organic brain syndromes
- •In the investigator's judgment, a significant risk of suicide or violent behavior"
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
bitopertin [RO4917838] 1
Experimental
干预措施: bitopertin [RO4917838] level 1 (Drug)
bitopertin [RO4917838] 2
Experimental
干预措施: bitopertin [RO4917838] level 2 (Drug)
结局指标
主要结局
Safety (incidence of adverse events)
时间窗: Week 12
Positive symptoms factor score assessed by Positive and Negative Syndrome Scale (PANSS)
时间窗: Change from baseline to Week 12
次要结局
- Symptom domains of schizophrenia using Positive and Negative Syndrome Scale (PANSS)(Change from baseline to Week 12)
- Disease severity on Clinical Global Impression - Severity (CGI-S) symptoms scale(Change from baseline to Week 12)
- Disease improvement on Clinical Global Impression - Improvement (CGI-I) symptoms scale(Change from baseline to Week 12)
- Safety (incidence of adverse events)(60 weeks)
研究者
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