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临床试验/NCT04489069
NCT04489069已完成不适用

Multimodal and Multi-source Study of Developmental Psychopathology in Twin and Youth Cohorts: Integration of Neuroimaging, Neuropsychology and Gene-environment Measures

IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
neurocognitive evaluation - tests assessing general IQ, ability to produce words, drawing skills, attention's ability, memory.

研究概览

简要总结

The present is a followup study that aims at investigating the effect of genetic and environmental factors on the possible development of psychopathological conditions in a longitudinal perspective.

The final goal is to understand those factors that causing vulnerability to mental illness, eventually allowing better prevention and early detections of those persons with mental illness.

详细描述

The developmental psychopathology aims at studying the possible paths that psychiatric conditions may take from childhood, through adolescence till early adulthood. This developmental perspective has the final goal of allowing prevention and early detection of mental illness, which in turn should translate into better prognosis and outcomes.

Longitudinal research allows a better grasp on the illness etiology as it gives the opportunity of directly investigate the possible causal mechanisms and of defining the origins of psychopathological condition in adults.

Many factors of risk interact, across neurodevelopment, in determining the person's vulnerability to mental illness. For instance, temperament and psychopathological factors were proved to have a role. However, the existing knowledge is still fragmented and should be integrated by new knowledge on genetic and environmental factors. Thus, combining observations of neurodevelopment, as measured with neuro-imaging techniques at subsequent timepoints, with psychopathological and neuropsychological evaluations, as well as with detailed information on genetic, environmental and temperamental indexes, is crucial, as no similar exhaustive investigations are still available.

Furthermore, it must be bared in mind that the gene by environment interaction generates complex epigenetic effects on neurodevelopment, which should be monitored through a longer time lapse.

This topic has been studying this topic for years, by research groups with sites in Friuli Venezia Giulia and Bosisio Parini (Lecco, Lombardia), by mean of cross-sectional and longitudinal studies, involving samples of children and adolescents at risk of psychopathology and referred because of behavioral and/or emotional difficulties, experienced in the past or still ongoing. Also, the research involved a cohort of Twins recruited from the normal population and whose data would allow more fine tuned analyses of the bene by environment interaction.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
15 Years 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • participants who already took part to the previous baseline evaluations carried out in our centers and signed consent to be contacted for future follow up

排除标准

  • Current or previous neurological illness or trauma that involved the brain.
  • Sensory impairments that can hamper the correct execution of the neurocognitive tasks and interviews.
  • Intellectual disability (i.e. IQ<70 as estimated with the Wechsler Adult Intelligence Scale or the Wechsler Intelligence Scale for Children)

研究组 & 干预措施

Clinical, neuropsychological and MRI evaluations

Other

干预措施: Drawing DNA sample (Diagnostic Test)

Clinical, neuropsychological and MRI evaluations

Other

干预措施: MRI (Diagnostic Test)

Clinical, neuropsychological and MRI evaluations

Other

干预措施: Clinical and Neuropsychological evaluations (Diagnostic Test)

结局指标

主要结局

neurocognitive evaluation - tests assessing general IQ, ability to produce words, drawing skills, attention's ability, memory.

时间窗: 2 hours

the output vary according to the test - they are accuracy scores (number of correct answers) or reaction times (milliseconds)

sample of saliva

时间窗: >10 minutes for drawing the sample

DNA single-nucleotide polymorphism from

MRI signal measuring the diffusion of weather particles across brain connections - Diffusion Tensor Imagning (DTI)

时间窗: 10 minutes

measures of the brain microstructure and connectivity - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)

clinical evaluation by mean of structures interviews - different interviews have different scales. In most of the cases the presence/absence of a psychiatric symptom is evaluated

时间窗: 2 hours

diagnosis or scores reflecting the degree of the presence or absence of a psychopathological condition or reflecting the personal temperament - The measures may vary on scales, for the most part the presence/absence (0-1) is recorded

Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures

时间窗: 10 minutes

anatomical images obtained with high definition T1 weighted sequences of radio frequencies - the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)

Functional Magnetic Resonance (fMRI) - MRI signal allowing to measure local brain's activity

时间窗: 20 minutes

BOLD signal reflecting the brain activity that is concurrent to the execution of the Continuous Performance Test associated to emotional stimuli, as well as at rest - as in all MRI techniques, the measure is a "signal (in Hz) to noise ratio" which is obtained from each voxel (tiny 3D portions of the brain)

次要结局

未报告次要终点

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (2)

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