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临床试验/NCT00206986
NCT00206986已完成不适用

Will Decreased Noradrenergic Activity Normalize Information Processing in Patients With Schizophrenia?

Birte Glenthoj1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年5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
40
试验地点
1
主要终点
The following psychophysiological measures:

研究概览

简要总结

The investigators want to try to improve information processing in schizophrenic patients via pharmacological intervention. The hypothesis is that decreased noradrenergic activity will normalize information processing (PPI, P50 gating, P300, and mismatch negativity) in patients with schizophrenia.

详细描述

A number of reports in literature provide evidence for, among others, an increased central noradrenergic activity in schizophrenia. In addition to this increased noradrenergic activity, patients with schizophrenia often show reduced filtering of sensory information, which is reflected in reduced P50 suppression and reduced prepulse inhibition of the startle reflex (PPI). In two separate initial studies in our laboratory, we found reduced sensory gating following administration of imipramine (a combined noradrenergic and serotonergic agonist) and desipramine (a highly specific noradrenergic agonist) to healthy volunteers. This provides evidence for a direct causal relation between the increased noradrenergic activity and the disturbed gating of sensory information, as both commonly found in patients with schizophrenia. Therefore, in a follow-up study, the effects of a noradrenergic antagonist will be investigated on the sensory gating of patients with schizophrenia. To further extend the data of our initial studies, the patients will additionally be tested for two psychophysiological parameters of attention that are usually found to be disturbed in patients with schizophrenia, i.e. mismatch negativity and selective attention. The design will conform to a double blind, placebo controlled experiment, in which either four doses (0.25 ug, 50 ug, 75 ug or 150 ug)of clonidine or placebo will be added to the current medical treatment of 20 male patients with schizophrenia on five occasions, separated by at least a week, after which they are tested in the Copenhagen Psychophysiological Test Battery (CPTB).In order to test the effects of clonidine in healthy volunteers, 20 healthy males will receive a fixed dose of 0.15 mg clonidine or placebo on two separate occasions separated by at least a week, after which they will be tested in the CPTB as well.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients:
  • Male subjects
  • Meeting the DSM-IV diagnosis of schizophrenia
  • Controls:
  • Male subjects
  • Good Physical and Mental Health meeting criteria "never mentally ill", which will be evaluated with a medical history checklist
  • Non smokers

排除标准

  • Patients:
  • A P50 suppression or PPI score falling within a range of 10 percent above or below the mean score of the healthy control group
  • Controls:
  • 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.

研究组 & 干预措施

1

Experimental

干预措施: clonidine (Drug)

2

Experimental

干预措施: clonidine (Drug)

结局指标

主要结局

The following psychophysiological measures:

时间窗: prospective

Prepulse Inhibition og the Startle Response (PPI)

时间窗: Once, 3.5 hrs after intake of capsule

P50 suppression

时间窗: Once, 3.5 hrs after intake of capsule

P300 Event Related Potential

时间窗: Once, 3.5 hrs after intake of capsule

Mismatch negativity

时间窗: Once, 3.5 hrs after intake of capsule

PANSS

时间窗: 5 times hourly after intake of capsule

次要结局

未报告次要终点

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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