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临床试验/NCT00207064
NCT00207064已完成不适用

5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs

Birte Glenthoj3 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2004年4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
46
试验地点
3
主要终点
5-HT2A receptor binding and occupancy (PET)

研究概览

简要总结

We want to relate disturbances in first-episode schizophrenic patients in serotonin 5-HT2A receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, we want to examine the influence of 5-HT2A receptor blockade on these disturbances. We expect disturbances in the serotonergic system at baseline to correlate with specific structural and functional changes and with disruption in information processing as measured with psychophysiological and neurocognitive methods - and we expect 5-HT2A receptor blockade to reverse some of the functional and cognitive impairments. We do not expect any effect of treatment on brain structure

详细描述

Patients and matched healthy controls are examined at baseline and again after the patients have been treated for 6 months with a combined 5-HT2A- and dopamine D2- receptor blocker. We have chosen the atypical antipsychotic compound, quetiapine, for the present study since this drug is characterized by a fast koff/low affinity for the dopamine D2 receptors. The purpose of the study is to examine pathophysiological and neuropsychological mechanisms - not treatment effects. We want to characterize neurobiological and functional endophenotypes or vulnerability indicators and to study their stability over time and their relation to treatment and contemporary psychopathology. To the extent that candidate endophenotypes can be characterized as stable and independent of treatment and contemporary psychopathology they will be analysed together with similar findings from previous (identical)cohorts of schizophrenic patients. Specific disturbances will also be related to candidate genes for schizophrenia.

研究设计

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

入排标准

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

入选标准

  • First-episode schizophrenia. The controls are matched for age, gender and parental socioeconomic status

排除标准

  • Previous antipsychotic treatment, mental retardation, organic brain damage, and for the controls a psychiatric diagnosis or first-degree relatives with a psychiatric diagnosis

研究组 & 干预措施

1

Experimental

干预措施: quetiapine (Drug)

结局指标

主要结局

5-HT2A receptor binding and occupancy (PET)

时间窗: Baseline and after 6 months

Structural MRI

时间窗: Baseline and after 6 months

Functional MRI

时间窗: Baseline and after 6 months

Information procession as measured with psychophysiological methods (P300, PPI, P50 gating ect.)

时间窗: Baseline and after 6 months

An extensive battery of neurocognitive measures

时间窗: Baseline and after 6 months

次要结局

  • PANSS(Baseline and after 6 months)

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 of Psychopharmacology and Neuropsychiatry, Danish Center for Neuropsychiatric Schizophrenia Research

University of Copenhagen

研究点 (3)

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