A Phase II, Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial of the Efficacy and the Safety of RO6889450 (Ralmitaront) vs Placebo in Patients With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 39
- 主要终点
- Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
研究概览
简要总结
This study will investigate the efficacy and safety of RO6889450 as monotherapy in participants experiencing an acute exacerbation of symptoms of schizophrenia or schizoaffective disorder.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants will receive oral placebo QD for 4 weeks. Participants from this arm that continue to the extension period will be randomized to either 45 mg or 150 mg QD of RO6889450 for up to an additional 8 weeks or additional 44 weeks (optional 36-Week Safety Extension Phase).
干预措施: Placebo (Drug)
4 mg QD Risperidone
Participants will receive 4 mg of risperidone QD for 4 weeks or 12 weeks or 48 weeks.
干预措施: Risperidone (Drug)
150 mg Once Daily (QD) RO6889450
Participants will receive 150 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks.
干预措施: RO6889450 (Drug)
45 mg QD RO6889450
Participants will receive 45 mg of RO6889450 QD for 4 weeks or 12 weeks or 48 weeks.
干预措施: RO6889450 (Drug)
结局指标
主要结局
Mean Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
时间窗: Week 4 (Day 28)
The PANSS is a 30-item rating scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. The Positive subscale is a 7-item scale that assesses features in schizophrenia that are not present in a normal mental state. The Negative subscale is a 7-item scale that assesses features absent in schizophrenia but present in those with a normal mental state. Items are rated on a 7-point scale, where 1 = absent and 7 = extreme, for a maximum score of 49 for each scale. The General subscale is a 16-item scale that assesses the overall severity of schizophrenia and the risk of aggression. Items are rated on the same scale, with a minimum score of 16 and a maximum score of 112. Total scores are calculated by adding subscale scores together, for a minimum score of 30 and a maximum score of 210. Higher scores indicate higher severity.
次要结局
- CGI-S up to Week 12(Up to Week 12)
- Participants Ready for Discharge From First Randomized Treatment Intake to Readiness for Discharge as Assessed by the Readiness for Discharge Questionnaire (RDQ) at 4-Week Treatment(after 4-week treatment)
- Proportion of Participants With at Least 20% or 50% Improvement in the PANSS Total Score up to Week 12(Weeks 4, 8, and 12)
- Change From Baseline in PANSS Factor Scores at Week 4(Week 4 (Day 28))
- Plasma Concentration of RO6889450(Day 7 - Day 336)
- Proportion of Participants With at Least 20% or 50% Improvement From Baseline in the PANSS Total Score(Baseline to Week 12)
- Change From Baseline in Clinical Global Impression Severity (CGI-S) Scores(Week 4 (Day 28))
- Clinical Global Impression - Improvement (CGI-I) Scores(Week 4 (Day 28))
- PANSS Total Score at Week 12(Week 12)
- CGI-I up to Week 12(Up to Week 12)