NCT02642068

Brief Summary

We anticipate that drug-naïve ADHD probands, particularly those with DAT1 or SLC6A2 gene variants may have higher level of altered microstructural integrity of frontostriatal (FS), frontoparietal (FP), other hypothesized fiber tracts and decreased brain activity of FS, FP, and other circuits, deficits in ERP, and impaired EF, SA, IIA and VM than probands without DAT1 or SLC6A2 gene variants or adult neurotypical. The alterations in the structural and functional connectivity, neurophysiological and neuropsychological functioning would be observed in the unaffected siblings as compared to neurotypical. The unaffected siblings will be in the intermediate position between drug-naïve adult ADHD probands and neurotypical. The genetic dosage is anticipated to pose the strongest effects on the cortical thickness, brain volume, gyrification and microstructural property of white matter, followed by neurophysiology, functional connectivity, and neuropsychological function with the least effect. In terms of longitudinal follow-up part, we also anticipated despite increasing thinning of cortical thickness, microstructural integrity of several targets fiber tracts, and brain activity of target brain regions and improving performance in EF, SA, IIV, VM from childhood to late adolescence and young adulthood in the neurotypical group, the slopes of developmental trajectories of these neuroimaging and neuropsychological function are lower in the ADHD group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

5 years

First QC Date

August 25, 2014

Last Update Submit

September 1, 2021

Conditions

Keywords

Drug-naïve Adult ADHDNeuropsychologyNeurophysiologyNeuroimagingFollow-up

Outcome Measures

Primary Outcomes (1)

  • Structural neuroimaging

    Using diffusing spectrum imaging (DSI) to assess the structural connectivity in frontostriatal, frontoparietal and other circuitries

    1 day

Secondary Outcomes (1)

  • Functional connectivity of the brain circuits

    1 day

Study Arms (3)

ADHD group

Drug-naïve adult ADHD Probands

Sibling group

Unaffected Siblings of Drug-naïve Adult ADHD

Control group

Age-, sex-, handedness-, and IQ-matched controls without lifetime ADHD or a family history of ADHD

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This 5-year proposal consists of two parts: (1) a 3-year case-control study with unaffected siblings and adult neurotypicals as controls to investigate the brain structural connectivity, functional connectivity, neurophysiological, neuropsychological functioning in 60 probands with ADHD, their unaffected siblings (at least 30 same-sex siblings, n=30\~60) and age-, sex-, handedness-, and IQ-matched neurotypicals (n=90\~120) with estimated total sample size as at least 180 up to 240. (2) a 2-year follow-up study to repeat the neuropsychological and MRI assessments and to assess electrophysiology related to inhibition controls of 40 adolescents and young adults with childhood diagnosis of ADHD and 40 neurotypicals who had same neuropsychological and imaging assessments in 2010.8-1013.7.

You may qualify if:

  • Subjects aged 16-30, who have clinical diagnosis of a ADHD according to the DSM-IV and DSM-5 diagnostic criteria, and who have never been treated with medication for ADHD treatment. At least 30 out of 60 subjects have same-sex unaffected siblings.

You may not qualify if:

  • The subjects will be excluded from the study if they meet any of the following criteria: (1) Comorbidity with DSM-IV-TR or DSM-5 diagnoses of autism spectrum disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment; and (4) Full-scale IQ lower than 80.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Related Publications (1)

  • Lee CY, Goh JOS, Gau SS. Differential neural processing of value during decision-making in adults with attention-deficit/hyperactivity disorder and healthy controls. J Psychiatry Neurosci. 2023 Mar 29;48(2):E115-E124. doi: 10.1503/jpn.220123. Print 2023 Mar-Apr.

Biospecimen

Retention: SAMPLES WITH DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

December 30, 2015

Study Start

August 1, 2014

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

September 2, 2021

Record last verified: 2021-09

Locations