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临床试验/NCT00612079
NCT00612079已完成不适用

The Effect of Sertindole on Sensory Gating and Cognition in Healthy Volunteers

University of Zurich1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年9月最近更新:
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

申办方类型
Other
责任方
Sponsor

研究点 (1)

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