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临床试验/NCT00206999
NCT00206999已完成不适用

Early Information Processing in Healthy Controls: Studies on the Relation Between Two Different Paradigms (PPI and P50ERP) and Effects of Pharmacological Interventions

Birte Glenthoj1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2004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
发起方
入组人数
20
试验地点
1
主要终点
Sensory gating

研究概览

简要总结

We wanted to compare the relation of two different psychophysiological paradigms (PrePulse Inhibition of the startle response = PPI and P50 suppression) to each other. Additionally, we wanted to test the effect of the combined serotonin- and noradrenaline re-uptake inhibitor, imipramine, on these measures. The primary hypothesis was that PPI and P50 gating would not correlate with each other at baseline. The secondary hypothesis was that increased noradrenergic and serotonergic activity would disrupt PPI as well as P50 gating.

详细描述

Schizophrenic patients exhibit impairments in filtering of sensory information, as can be assessed by use of prepulse inhibition (PPI) of the acoustic startle response and P50 suppression paradigms. In the treatment of negative symptoms or depressive syndromes during the course of schizophrenia antidepressants are often combined with antipsychotic medication. However, antidepressants increase monoaminergic activity, of which in turn it has been suggested to decrease sensory gating, although these presumptions are mostly based on results from animal studies. Currently, little is known about monoaminergic modulation of sensory filtering in humans, and the few reports that can be found in literature show discrepancies with animal studies. The current study was designed to study the effects of increased monoaminergic activity on sensory filtering and habituation of healthy volunteers. In a double-blind, placebo controlled cross-over design, twenty healthy male volunteers will receive either placebo or a dose of 50 mg of imipramine (a dual acting antidepressant), after which they will be tested in a P50 suppression-, a PPI-, and a habituation of the startle reflex paradigm.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male subjects
  • Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist, ECG
  • Non smokers

排除标准

  • Current use of any medication
  • Any subject who has received any investigational medication within 30 days prior to the start of this study
  • History of neurologic illness
  • History of psychiatric illness in first-degree relatives, evaluated with DSM-IV criteria
  • History of alcohol and drug abuse. Positive urine screening for amphetamine, cocaine, cannabis, or ecstasy.

研究组 & 干预措施

1

Experimental

干预措施: imipramine (Drug)

结局指标

主要结局

Sensory gating

时间窗: Once, 1 hour after administration of capsule

次要结局

  • PPI of the startle reflex(once, one hour after administration)
  • P50 suppression(once, one hour after administration)

研究者

发起方
Birte Glenthoj
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Birte Glenthoj

Professor

University of Copenhagen

研究点 (1)

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