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临床试验/NCT01154829
NCT01154829已完成不适用

Pan European Collaboration on Antipsychotic Naive Schizophrenia (PECANS): the Effects of D2 Antagonism on Candidate Endophenotypes

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2008年12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
入组人数
136
试验地点
1
主要终点
Relationship between specific neuropsychiatric measures and improvement on PANSS scores

研究概览

简要总结

The investigators want to relate disturbances in first-episode schizophrenic patients in (dopaminergic) D2 receptors, brain structure, brain function, and information processing to each other and to psychopathology. Additionally, the investigators want to examine the influence of D2 receptor blockade on these disturbances. The investigators expect disturbances in the dopaminergic 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 investigators expect D2 receptor blockade to reverse some of the functional and cognitive impairments.

详细描述

The study is designed as a 6 week case-control follow-up study of 70 AN FE pt. with SCZ and 70 controls matched with regard to age, gender, and parental socio-economic status. All subjects will be examined with a diagnostic interview (SCAN, Schedule for Clinical Assessment in Neuropsychiatry), medical and family history, and physical examination before inclusion. At baseline all subjects will be examined with single photon emission computed tomography (SPECT), MRI, fMRI, psychophysiology, neurocognition. In addition, they will be screened for drugs, genetic testing, and ECG. Patients will further be examined with clinical validated rating scales to measure psychopathology, subjective well-being, and side-effects. After a period of 6 weeks all assessments are repeated. During that period patients will be treated with amisulpride, while healthy controls will receive no treatment at all. Efficacy of antipsychotic treatment will be evaluated after this initial period of 6 weeks. Based on this evaluation it will be decided to either continue the current (amisulpride) antipsychotic treatment, or to switch to aripiprazole. Efficacy of aripiprazole is evaluated on a monthly basis, if the patient does not respond well enough, than the treatment will be adapted individually. Regardless of treatment, all subjects will be re-assessed in the same test battery as mentioned above, except for SPECT and fMRI, after a period of 6, 12, and 24 months. The developement in specific disturbances and the relationship between these will be analysed.

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

  • For patients: meeting diagnostic criteria for schizophrenia according to ICD 10 or DSM IV antipsychotic naive The controls will be matched to the patients according to gender age and parental socio-economic status.

排除标准

  • Patients: mental retardation, other chronic diseases, use of antidepressive medicine during the last month,being pregnant, on going substance abuse
  • Controls: psychiatric diagnosis, psychiatric diagnosis in first-degree relatives,on going drug abuse, mental retardation -

研究组 & 干预措施

first choice treatment

Active Comparator

Treatment with amisulpride

干预措施: amisulpride (Drug)

second choice treatment

Active Comparator

treatment with aripiprazole

干预措施: aripiprazole (Drug)

结局指标

主要结局

Relationship between specific neuropsychiatric measures and improvement on PANSS scores

时间窗: 6 weeks of medical treatment

次要结局

  • The relation between D2 binding potential (SPECT) and reward related brain activity (fMRI BOLD response) before and after D2 blockade(Baseline, 6 weeks)
  • Time/dose improvement on PPI and other psychophysiological measures of early information processing after D2 blockade(Baseline, 2 and 6 weeks, 6,12,24 months)
  • Cognitive differences at baseline and changes over time after D2 blockade(Baseline, 6 weeks, 6,12,24 months)
  • Disturbances in reward related fMRI BOLD response in antipsychotic naive schizophrenic patients(Baseline and 6 weeks follow up)
  • Structural changes in grey and white matter before and after D2 blockade(6 weeks, 6, 12 and 24 months,)
  • The effect of D2 blockade on reward related fMRI BOLD response(6 weeks of medical treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Birte Glenthoj

professor

University of Copenhagen

研究点 (1)

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