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临床试验/NCT02339844
NCT02339844已完成4 期

Pan European Collaboration on Antipsychotic Naïve Schizophrenia II

University of Copenhagen1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2014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
已完成
入组人数
130
试验地点
1
主要终点
Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy)

研究概览

简要总结

The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined after 6 weeks, 6 months and 2 years. They will be examined with MR-scannings, neurocognitive tests, EEG, and PET-scannings.

详细描述

The study is a prospective 2 year multimodal follow-up study of initially antipsychotic-naïve first-episode psychotic patients involving a standardized intervention with monotherapy with aripiprazole during the first 6 weeks. Patients and matched healthy controls will be examined at baseline and after 6 weeks, 6 months and 2 years.

Levels of glutamate and gamma-aminobutyric acid (GABA) are measured by proton magnetic resonance spectroscopy (1H-MRS) in the anterior cingulate cortex ACC and thalamus. Presynaptic Dopamine level is measured with Positron Emission Tomography Computed Tomography (PET/CT)-scanning using 3,4-dihydroxy-6-[18F]fluoro-L-phenylalanine (18F-DOPA). Disturbances of the reward system is measured with functional magnetic resonance imaging (fMRI) . Regional cerebral blood flow and activity in the same regions are measured with Pseudo-continuous arterial spin labelling (pCASL). The default mode network, functional and structural connectivity in the associated macro circuits are measured with resting state fMRI, EEG, and diffusion tensor imaging. Structural brain changes (in grey and white matter) are measured with MRI. Cognitive functions are measured with a neuropsychological test battery, and early information processing with event related EEG and electromyography (EMG) (psychophysiological examinations). Further patients psychopathology will be rated.

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 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

antipsychotic treatment

Active Comparator

individual doses of aripiprazole for all patients

干预措施: Aripiprazole (Drug)

结局指标

主要结局

Glutamate level in Anterior Cingulate Cortex (measured with magnetic resonance spectroscopy)

时间窗: Baseline, 6 weeks, 6 months, 2 years

Glutamate level at baseline and change over time as measured with magnetic resonance spectroscopy

次要结局

  • Cortical thickness (measured with magnetic resonance and free surfer)(Baseline, 6 weeks, 6 months & 2 years)
  • Dopamine syntheses capacity in striatum (measured with F-DOPA using Positron emission tomography)(Baseline and 6 weeks follow up)
  • Reward system activation in striatum (measured with functional magnetic resonance imaging)(Baseline and 6 weeks follow up)
  • Neurocognition (measured with BACS (Brief Assessment of Cognition in Schizophrenia) and CANTAB (Cambridge Neuropsychological Test Automated Battery)(Baseline, 6 weeks, 6 months & 2 years)
  • Psychopathology (measured with PANSS (Positive and Negative Syndrome Scale)(Baseline, 6 weeks, 6 months & 2 years)
  • Prepulse inhibition of the startle reflex and reduced P50 suppression ( measured with event related EEG and EMG)(Baseline, 6 weeks, 6 months & 2 years)

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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