Developmental Psychopathology and the Gene-environment Interaction

NCT04489069 | Completed

• 1 other identifier: 212/2019-VERSIONE2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Developmental Psychological Disorder

Outcome Measures

Primary Outcomes (6)

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

  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)

  10 minutes

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

  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)

  10 minutes

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

  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)

  20 minutes

• 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

  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

  2 hours

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

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

  2 hours

• sample of saliva

  DNA single-nucleotide polymorphism from

  >10 minutes for drawing the sample

Study Arms (1)

Clinical, neuropsychological and MRI evaluations

OTHER

Diagnostic Test: MRI; Diagnostic Test: Clinical and Neuropsychological evaluations; Diagnostic Test: Drawing DNA sample

Interventions

MRI DIAGNOSTIC_TEST

Magnetic Resonance Imaging (sturctural MRI, fMRI resting state and task related, DTI)

Clinical, neuropsychological and MRI evaluations

Clinical and Neuropsychological evaluations DIAGNOSTIC_TEST

Clinical interviews and neuropsychological tests (paper/pencil and computer based)

Clinical, neuropsychological and MRI evaluations

Drawing DNA sample DIAGNOSTIC_TEST

Saliva sample

Clinical, neuropsychological and MRI evaluations

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E.Medea

San Vito al Tagliamento, Pordenone, 33078, Italy

Location

Study Officials

• Carolina Bonivento, PhD

  IRCCS E.Medea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: July 28, 2020
• Study Start: January 16, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)