A Randomized, Double-Blind, Placebo-Controlled Parallel Arm Study of the Effect of RO4917838 on Biomarker Measures of Cognitive Dysfunction in Schizophrenia and Schizoaffective Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
研究概览
简要总结
This randomized, double-blind, placebo-controlled parallel group study will assess the effect on biomarkers measures of cognitive dysfunction, the clinical efficacy and safety of RO4917838 in participants with schizophrenia and schizoaffective disorder. Participants will be randomized to receive either RO4917838 (10 milligrams [mg] daily orally) or placebo for 6 weeks, in addition to their stable antipsychotic medication. Anticipated time on study treatment is 6 weeks.
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
- •Diagnosis of schizophrenia or schizoaffective disorder (based on screening tests)
- •Medically stable for 1 month and psychiatrically stable without symptom exacerbation for 6 weeks prior to baseline
- •On stable treatment with a maximum of 2 antipsychotics
排除标准
- •Change in regimen for any psychotropic or sleep medication within 1 month
- •Treatment with more than (>) 1 mood stabilizer or antidepressant
- •Use of clozapine within 2 months
- •Bipolar disorder, or more than mild anxiety disorder
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Placebo
干预措施: Standard Antipsychotic Therapy (Drug)
RO4917838
干预措施: RO4917838 (Drug)
RO4917838
干预措施: Standard Antipsychotic Therapy (Drug)
结局指标
主要结局
Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 6, as Measured Using Electroencephalography (EEG)
时间窗: Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 6, as Measured Using EEG
时间窗: Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 6, as Measured Using EEG
时间窗: Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 6, as Measured Using EEG
时间窗: Baseline, Week 6
Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 6, as Measured Using EEG
时间窗: Baseline, Week 6
次要结局
- Change From Baseline in Cognitive Dysfunction Biomarker (Mismatch Negativity) at Week 1, as Measured Using EEG(Baseline, Week 1)
- Change From Baseline in Cognitive Dysfunction Biomarker (Visual Event-Related Potential [ERP]) at Week 1, as Measured Using EEG(Baseline, Week 1)
- Change From Baseline in Cognitive Dysfunction Biomarker (N1 Refractoriness) at Week 1, as Measured Using EEG(Baseline, Week 1)
- Change From Baseline in Cognitive Dysfunction Biomarker (P3 Component) at Week 1, as Measured Using EEG(Baseline, Week 1)
- Positive Predictive Value of Cognitive Dysfunction Biomarkers (Mismatch Negativity, ERP, N1 Refractoriness, P3 Component, and VEP) Change at Week 1 to Predict the Presence of Biomarker Response at Week 6, as Measured Using EEG(Baseline, Weeks 1 and 6)
- Positive Predictive Value of Cognitive Dysfunction Biomarkers (Mismatch Negativity, ERP, N1 Refractoriness, P3 Component, and VEP) Change at Week 1 to Predict the Change in Symptoms at Week 6, as Measured Using EEG(Baseline, Weeks 1 and 6)
- Change From Baseline in Positive and Negative Syndrome Scale Score(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Negative Symptom Assessment Score(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Clinical Global Impression Scale(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Calgary Depression Scale Score(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Global Assessment of Functioning Score(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Cognition Battery Score(Baseline, Weeks 1, 3, and 6)
- Change From Baseline in Cognitive Dysfunction Biomarker (Visual Evoked Potential [VEP]) at Week 1, as Measured Using EEG(Baseline, Week 1)