NCT00937261Unknown4 期
Contrasting the Brain Effects of Risperidone and Invega With fMRI and PET Scanning
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
研究概览
简要总结
The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.
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
- Triple (Participant, Care Provider, 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
- •are currently taking Risperdal and have been on the medication for at least three weeks
- •are diagnosed with schizophrenia
- •are able to provide written informed consent
- •can safely have an MRI
排除标准
- •are treatment resistant or intolerant to Risperdal
- •have participated in another drug study in the past 28 days
- •are pregnant or trying to become pregnant or are breastfeeding
- •are colorblind
- •have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study
- •have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant
- •certain medications are also exclusionary including aripiprazole.
研究组 & 干预措施
Risperdal
Experimental
Risperdal 2-8mg per day
干预措施: Risperidone (Drug)
Invega
Experimental
Invega 6-12mg per day
干预措施: Paliperidone (Drug)
结局指标
主要结局
Comparison of BOLD signal activation and FDG metabolism of the DLPFC, superior temporal gyrus and amygdala, and their interaction between Invega and Risperdal
时间窗: approximately 6-10 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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