NCT02232464

Brief Summary

Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive deficits may last to adulthood. Our previous studies, like western results, have shown that children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways and impaired brain activity in frontoparietal network. However, there is lack of data with regards to whether adults with ADHD also demonstrate structural and functional disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls without ADHD in Asian population and no study has been done to correlate a wide range of executive functions with the connectivity of these two networks. Specific Aims:

  1. 1.to compare the executive functions, and structural and functional connectivity in frontostriatal and frontoparietal circuitries between adults with ADHD and healthy controls without ADHD;
  2. 2.to correlate the data from structural and functional connectivity, executive functions, and ADHD core symptoms stratifying by the ADHD and controls; and
  3. 3.to explore other circuitries that may involve in ADHD by using whole brain tractography analyses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 18, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

August 27, 2014

Last Update Submit

March 16, 2015

Conditions

Keywords

Adult ADHDdiffusion spectrum imagingresting-state fMRIfrontostriatal circuitriesfrontoparietal circuitriesexecutive function

Outcome Measures

Primary Outcomes (1)

  • Structural neuroimaging

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

    one day

Secondary Outcomes (1)

  • Functional connectivity of the brain circuits

    one day

Study Arms (2)

ADHD group

Adults with clinical diagnosis of ADHD according to the DSM-IV criteria

Control group

Age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample consists of 50 adults (ages 18-45) with clinical diagnosis of ADHD according to the DSM-IV criteria and 50 age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD.

You may qualify if:

  • Subjects aged 18-45, who have clinical diagnosis of a ADHD according to the DSM-IV criteria.

You may not qualify if:

  • The subjects will be excluded from the study if they meet any of the following criteria: (1) Comorbidity with 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

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 27, 2014

First Posted

September 5, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 18, 2015

Record last verified: 2015-03

Locations