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Clinical Trials/NCT04489069
NCT04489069CompletedNot Applicable

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

IRCCS Eugenio Medea2 sites in 1 country40 target enrollmentStarted: January 16, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
2
Primary Endpoint
neurocognitive evaluation - tests assessing general IQ, ability to produce words, drawing skills, attention's ability, memory.

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
15 Years to 35 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Arms & Interventions

Clinical, neuropsychological and MRI evaluations

Other

Intervention: Drawing DNA sample (Diagnostic Test)

Clinical, neuropsychological and MRI evaluations

Other

Intervention: MRI (Diagnostic Test)

Clinical, neuropsychological and MRI evaluations

Other

Intervention: Clinical and Neuropsychological evaluations (Diagnostic Test)

Outcomes

Primary Outcomes

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

Time Frame: 2 hours

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

sample of saliva

Time Frame: >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)

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
IRCCS Eugenio Medea
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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