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临床试验/NCT00567099
NCT00567099Unknown不适用

Remediation of Schizophrenia Sensory Gating Deficit With Aripiprazole

New Mexico VA Healthcare System2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2003年8月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
2
主要终点
MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month.

研究概览

简要总结

The purpose of this study is the use of magnetoencephalography or MEG (a machine that measures magnetic activity in your brain) and electroencephalography or EEG (a technique that measures electrical activity in your brain) to study how sounds are processed in individuals with schizophrenia prior to initiation with aripiprazole treatment and after three months of taking the antipsychotic medication aripiprazole.

详细描述

Problems with attention and perception are core features of schizophrenia and are hypothesized to result from defects in the filtering or gating of sensory input. Examination of this requires neuroimaging techniques with high temporal resolution. High-density EEG and MEG in combination with structural magnetic resonance imaging (sMRI) are used to map sensory gating. In a number of recent studies patient treated with novel antipsychotics have been shown to have P50 gating ratios resembling those of normal controls rather than that of schizophrenia subjects treatment with conventional antipsychotics. To date, there is no literature on the effects of aripiprzole on sensory gating. Subjects who meet all inclusion criteria will receive a clinical interview, an MRI, MEG, and neuropsychological testing before starting treatment with aripiprazole and again 3 months later to determine if patients with schizophrenia who are treated with aripiprazole will demonstrate a sensory gating ratio similar to normal controls, indicating no deficit in sensory gating

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • Patient Population
  • Diagnosis of Schizophrenia as determine by the Structured Clinical Interview for DSM-IV
  • no comorbid diagnosis of PTSD
  • continuous treatment with a conventional antipsychotic, risperidone or olanzapine for at least 3 months
  • absence of psychiatric hospitalization for at least 3 month
  • no history of drug dependency in their lifetime
  • no history of alcohol or other substance abuse in the 6 months prior to entry into the study
  • no history of head injury with loss of consciousness for more than 5 minutes
  • no history of seizure disorder
  • no mood stabilizing agents
  • between 18-65 and
  • able to sign informed consent
  • Normal Controls
  • Matched in age and gender to patient population
  • No history of psychiatric dysfunction or alcohol or other substance dependence in their lifetime as determine by the SCID
  • No history of alcohol or other substance abuse in the previous 6 months
  • No family history of psychotic disorder in first degree relatives as assessed by the FH-RDC diagnostic interview
  • No history of head injury with loss of consciousness for more than 5 minutes
  • No history of seizure disorder
  • Between 18-65
  • Able to sign informed consent

排除标准

  • Subjects will be excluded from participating in this study if they:
  • Require treatment with a mood stabilizer
  • Have had an inpatient hospitalization in the past 3 months\
  • Have a history of a neurological disorder
  • Have any other axis I diagnosis besides schizophrenia

结局指标

主要结局

MEG/EEG and MRI data will be compared with the results of a neuropsych battery and symptom rating scales prior to initiation with aripiprazole and after subject has been on a stable dose of aripiprazole for three month.

时间窗: MEG/EEG will be repeated after a min. of three months on a stable dose of Aripiprazole

次要结局

未报告次要终点

研究者

发起方
New Mexico VA Healthcare System
申办方类型
Fed

研究点 (2)

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