NCT00612079已完成不适用
The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
研究概览
简要总结
This study aims to further validate and extend our previous findings insofar that the effect of the atypical antipsychotic and mixed 5-HT2/D2 antagonist sertindole on sensorimotor gating processes and its relationship to cognitive performance shall be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age: 18-40
- •Gender: male
排除标准
- •Axis I Disorders: lifetime DSM IV diagnosis according to DIA-X of alcohol or illicit drug dependence. No life-time DSM IV diagnosis according to DIA-X of a major affective, psychotic, anxiety disorder, eating-disorder as defined above.
- •Axis II Disorders: lifetime DSM IV diagnosis of personality disorder according to SCID-II.
- •Family history: lifetime history of 1st degree relative (parents and siblings) of a major affective, psychotic, or anxiety disorder as defined above.
- •ECG: QTc-interval >450 msec.
- •Systolic blood pressure <100 mmHg
- •Bradycardia (Hf < 50/Min) und Arrhythmias
- •Hypokalemia or Hypomagnesemia
研究组 & 干预措施
2
Experimental
Healthy volunteers with high sensory gating levels.
干预措施: Placebo (Drug)
1
Experimental
Healthy volunteers with low sensory gating levels.
干预措施: Placebo (Drug)
2
Experimental
Healthy volunteers with high sensory gating levels.
干预措施: Sertindole (Drug)
1
Experimental
Healthy volunteers with low sensory gating levels.
干预措施: Sertindole (Drug)
结局指标
主要结局
Sensory (EEG: P50 suppression) and sensorimotor gating (EMG: PPI)
时间窗: after placebo and and after medical treatment
次要结局
- Cognitive performances(after placebo and and after medical treatment)
研究者
研究点 (1)
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