Randomized, Double-blind, Placebo-controlled add-on Trial of the Safety and Efficacy of RO4917838 in Outpatients on Select Atypical Antipsychotics With Prominent Negative or Disorganized Thought Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 323
- 主要终点
- Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
研究概览
简要总结
This study will determine the efficacy and safety of RO4917838 in patients with schizophrenia who are stable on current antipsychotic treatment (olanzapine, que tiapine, risperidone, paliperidone or aripiprazole) with prominent negative or d isorganized thought symptoms. After a 4 week run in period on their current anti psychotic treatment, patients will be randomized to receive placebo 10mg, 30mg, or 60mg of RO4917838 once daily, p.o., as add-on therapy. The anticipated time o n study treatment is <3 months, and the target sample size is 100-500 individual s.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-60 years of age;
- •diagnosis of schizophrenia (based on screening tests);
- •outpatients, with no hospitalization for worsening of schizophrenia within 3 months;
- •medically and psychiatrically stable over prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months;
- •currently taking no more than 2 antipsychotic drugs.
排除标准
- •began a new non-medication treatment for schizophrenia or other psychiatric condition within last 3 months;
- •on >1 antidepressant, or a change in dose of antidepressant within 3 months;
- •alcohol or substance abuse or dependence within 3 months;
- •has previously received RO4917838.
研究组 & 干预措施
2
干预措施: Standard antipsychotic therapy (Drug)
3
干预措施: RO4917838 (Drug)
3
干预措施: Standard antipsychotic therapy (Drug)
4
干预措施: Placebo (Drug)
4
干预措施: Standard antipsychotic therapy (Drug)
1
干预措施: RO4917838 (Drug)
1
干预措施: Standard antipsychotic therapy (Drug)
2
干预措施: RO4917838 (Drug)
结局指标
主要结局
Mean change from baseline in PANSS (Positive and Negative Syndrome Scale) negative factor score.
时间窗: Week 8
次要结局
- Change from baseline in total PANSS score, CGI, PSP, SGLS; cognition status changes.(Throughout study)
- AEs, laboratory parameters, C-SSRS(Throughout study)