Developmental Psychological DisorderTwinAgerNCT04489069
Developmental Psychopathology and the Gene-environment Interaction
A study testing MRI, Clinical and Neuropsychological evaluations and Drawing DNA sample in people with Developmental Psychological Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Psychological Disorder
- What is being tested?
- MRI, Clinical and Neuropsychological evaluations and Drawing DNA sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multimodal and Multi-source Study of Developmental Psychopathology in Twin and Youth Cohorts: Integration of Neuroimaging, Neuropsychology and Gene-environment Measures
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.
Read the 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.
In those first phases of study, instruments assessing the psychopathological risk were adapted to the Italian population and the associated cognitive marker were identified.
Also, some analysis investigated the effect of the environment on the psychopathological risk. Moreover, the influence of genetic factors is under now study, mainly focussing on epigenetic factors.
The research that is presented here is the followup of the previous investigations. In the previous year (2019) 33 participants underwent the follow up from the sample of children at psychopathological risk and who were chidden/adolescents at the time of the baseline evaluation.
During the current year the Twins cohort will be followed up. Half or more of the participants tested ad the baseline are expected to participate, which correspond to about 30 couples (60 participants). The subjects will undergo i) a magnetic resonance, including structural MRI, DTI, resting state fMRI, fMRI (during the fMRI sequences a concurrent task, tapping attention and emotional processes, is presented); ii) a psychopathological evaluation; iii) a self-rating evaluation, filling questionnaires measuring temperaments and assessing the possible presence of behavioral problems; iv) a neurocognitive evaluation; v) a drawing of biological-genetic sample (saliva).
- Conditions
- Developmental Psychological Disorder
- Being tested
- MRI, Clinical and Neuropsychological evaluations, Drawing DNA sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
Magnetic Resonance Imaging (sturctural MRI, fMRI resting state and task related, DTI)
Clinical and Neuropsychological evaluationsDiagnostic test
Clinical interviews and neuropsychological tests (paper/pencil and computer based)
Drawing DNA sampleDiagnostic test
Saliva sample
| Study group | Role | What they receive |
|---|---|---|
| Clinical, neuropsychological and MRI evaluations | Other | Not described Receives: Diagnostic Test: MRI; Diagnostic Test: Clinical and Neuropsychological evaluations; Diagnostic Test: Drawing DNA sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 2 hours
sample of saliva
DNA single-nucleotide polymorphism from
Measured: >10 minutes for drawing the sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start16 Jan 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Psychological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Bonivento, PhD, Principal investigator, IRCCS E.Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489069
- Sponsor's protocol ID
- 212/2019-VERSIONE2
- Acronym
- TwinAger
- Status last verified
- Mar 2024
- First submitted
- 30 Mar 2020
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal and Multi-source Study of Developmental Psychopathology in Twin and Youth Cohorts: Integration of Neuroimaging, Neuropsychology and Gene-environment Measures
- ClinicalTrials.gov ID
- NCT04489069
- Acronym / sponsor ID
- TwinAger / 212/2019-VERSIONE2
- Conditions
- Developmental Psychological Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In those first phases of study, instruments assessing the psychopathological risk were adapted to the Italian population and the associated cognitive marker were identified.
Also, some analysis investigated the effect of the environment on the psychopathological risk. Moreover, the influence of genetic factors is under now study, mainly focussing on epigenetic factors.
The research that is presented here is the followup of the previous investigations. In the previous year (2019) 33 participants underwent the follow up from the sample of children at psychopathological risk and who were chidden/adolescents at the time of the baseline evaluation.
During the current year the Twins cohort will be followed up. Half or more of the participants tested ad the baseline are expected to participate, which correspond to about 30 couples (60 participants). The subjects will undergo i) a magnetic resonance, including structural MRI, DTI, resting state fMRI, fMRI (during the fMRI sequences a concurrent task, tapping attention and emotional processes, is presented); ii) a psychopathological evaluation; iii) a self-rating evaluation, filling questionnaires measuring temperaments and assessing the possible presence of behavioral problems; iv) a neurocognitive evaluation; v) a drawing of biological-genetic sample (saliva).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical, neuropsychological and MRI evaluations | Other | Diagnostic Test: MRI, Diagnostic Test: Clinical and Neuropsychological evaluations, Diagnostic Test: Drawing DNA sample |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMagnetic Resonance Imaging (sturctural MRI, fMRI resting state and task related, DTI) | Diagnostic test | Clinical, neuropsychological and MRI evaluations |
| Clinical and Neuropsychological evaluationsClinical interviews and neuropsychological tests (paper/pencil and computer based) | Diagnostic test | Clinical, neuropsychological and MRI evaluations |
| Drawing DNA sampleSaliva sample | Diagnostic test | Clinical, neuropsychological and MRI evaluations |
Primary outcome
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)
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)
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)
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Bonivento, PhD principal investigator
IRCCS E.Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Clinical and Neuropsychological evaluations and Drawing DNA sample in people with Developmental Psychological Disorder, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance (MRI) of the Brain - MRI signal allowing tridimensional multiplanar reconstruction of the brain's structures (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.