NCT00419653终止4 期
Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy With Amisulpride, Olanzapine or Haloperidol. A Study With Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI)
University of Jena0 个研究点目标入组 19 人开始时间: 2003年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 主要终点
- Activation/deactivation in fMRI
研究概览
简要总结
The study aims to investigate the modulation of regional brain activation in schizophrenic patients by psychopharmacological treatment with either haloperidol, amisulpride or olanzapine. The study will be performed with functional magnetic resonance imaging (fMRI) and diffusion tensor imaging (DTI).
详细描述
The current study aims to investigate the following issues:
- Changes in cognitive activation patterns under therapy with the typical neuroleptic haloperidol as compared to the atypical antipsychotics amisulpride and olanzapine
- Relationship of these changes in activity to psychopathological, neuropsychological and pharmacotherapeutic variables (e.g. drug plasma level) as well as to certain biological markers (HVA, prolactin)
- Relationship between diffusion anisotropy as an indicator for structural connectivity and cognitive activation patterns under antipsychotic treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •In- and outpatients of either sex
- •Able to comply with the protocol
- •Having given their written informed consent of their own free will
- •Total BPRS (PANSS-derived, 1-7 points) minimum 36 points at baseline
- •Schizophrenic or schizophreniform disorder according to DSM-IV criteria (295.10, .30, .40, .90)
- •Definite right-handedness (according to the modified Edinburgh Handedness Inventory)
- •Age 18 - 50 years
排除标准
- •Co-morbid psychiatric axis I disorder (DSM-IV) other than schizophrenia
- •Axis II disorder according to DSM-IV
- •Present or past history of substance and drug dependence (including alcohol dependence)
- •Participation in a clinical trial within the previous three months
- •Lack of insight
- •Suicidal ideations or aggression against others
- •Consumption of caffeine-containing beverages within 6 hours before assessments
- •Clinically significant findings in ECG or EEG
- •Known intolerance against neuroleptics
研究组 & 干预措施
1
Experimental
干预措施: Amisulpride (Drug)
2
Active Comparator
干预措施: Olanzapine (Drug)
3
Active Comparator
Haloperidol
干预措施: Haloperidol (Drug)
结局指标
主要结局
Activation/deactivation in fMRI
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
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