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临床试验/NCT00288340
NCT00288340已完成不适用

Quantifying Abnormalities in Cortical Activation Associated With Auditory Hallucinations Using Functional Magnetic Resonance Imaging

Vanderbilt University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
characterize abnormalities in brain structure and function related to schizophrenia

研究概览

简要总结

The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. The investigators will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment.

详细描述

The goal of the project is to characterize abnormalities in brain structure and function related to schizophrenia. We will use advanced magnetic resonance imaging (MRI) techniques to measure the degree and distribution of neuronal activity during specific cognitive tasks, alterations in neuronal connectivity, and how these are related to disease symptoms and treatment. We will focus on changes in brain structure and function associated with frequent auditory hallucinations, one of the most disabling manifestations of schizophrenia, and with neuroleptic treatment. In order to address these aims, we will study four groups of subjects:

  1. patients who have frequent auditory hallucinations,
  2. patients who are beginning a regimen of anti-psychotic medication,
  3. patients who do not have frequent hallucinations and are not changing medication strategies, and
  4. age-matched normal controls. Each group will contain 15 subjects for a total of 60.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Investigators will study subjects who:
  • Are between the ages of 18 and
  • Meet diagnostic criteria for any psychiatric disorder with auditory hallucinations (at least one every 20 minutes) including schizophrenia/schizoaffective disorder OR schizophrenia/schizoaffective disorder without auditory hallucinations.
  • Have been treated with an antipsychotic drug for hallucinations at least three months or are unmedicated
  • Are willing to change their current antipsychotic medication if indicated
  • Are able to provide written consent
  • Normal controls must :
  • Be between the ages of 18 and 65
  • Not meet the diagnostic criteria for schizophrenia or schizoaffective disorder or other psychiatric disorder involving hallucinations
  • Not currently be treated with an antipsychotic drug
  • Be able to provide written consent

排除标准

  • Subjects and normal controls will be excluded from participation if there is:
  • Evidence of non-psychiatric, chronic central nervous system (CNS) disease (such as brain injury or neurological disease)
  • Contraindication to MRI, including prior claustrophobic reaction and severe movement disorder
  • A recent change in menstrual status other than recent changes in oral or implanted contraceptive use (for females)
  • A positive pregnancy result (for females)

结局指标

主要结局

characterize abnormalities in brain structure and function related to schizophrenia

时间窗: two scans over a six month period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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