NCT00008892

Brief Summary

The purpose of this study is to use brain imaging technology to study the connections between brain regions in children with attention deficit hyperactivity disorder (AD/HD), and comparing them to children without AD/HD. This study will build upon previous brain imaging studies of healthy volunteers and children who have AD/HD. This study will use diffusion tensor magnetic resonance imaging (DT-MRI) to visualize and measure certain parts of the brains of identical twin pairs in which one twin has AD/HD, combined type. Participants in this study will be screened with questionnaires and interviews, psychometric testing, and a physical examination. Participants' medical and educational records may be reviewed. Participants will undergo an MRI scan of the brain. Prior to the MRI, participants will have a training session in a simulated MRI scanner to learn how to lie still during MRI scanning. Participants may be asked to return for a follow-up scan in about 2 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2001

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2001

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 19, 2001

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2007

Completed
Last Updated

July 2, 2017

Status Verified

January 31, 2007

First QC Date

January 18, 2001

Last Update Submit

June 30, 2017

Conditions

Attention Deficit Disorder With HyperactivityHealthy

Keywords

Magnetic Resonance ImagingDiffusion Tensor ImagingTwin StudyAttention Deficit Hyperactivity DisorderNormal Volunteers

Eligibility Criteria

Age6 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PILOT SUBJECTS:
  • MONOZYGOTIC TWINS:
  • Subjects must be monozygotic twins (MZ) as confirmed by twin-similarity questionnaire and by molecular cheek swab testing by polymerase chain reaction short tandem repeat multiplex loci sets to find differences in the DNA types of the two co-twins. The primary test set includes nine to fourteen unlinked loci with a combined matching probability for siblings p less than .0001. Cases yielding a probability of twinship less than 0.99 are tested further to a total of 21 loci. Subjects may also be requested to participate in an associated genetic protocol (96-M-0060).
  • ADHD PROBANDS:
  • Monozygotic twin.
  • Aged 6 - 21 years.
  • DSM-IV diagnosis of ADHD (inattentive, hyperactive-impulsive and combined types).
  • Age adjusted dimensional ratings (Conners Rating Scales-Revised, or Strengths and Weaknesses of ADHD and Normal Behavior (SWAN)) hyperactivity/impulsivity greater than or equal to 95th percentile in affected twin.
  • Consent and assent obtained in writing.
  • NORMAL PEDIATRIC VOLUNTEERS:
  • Except for pilot subjects (up to 10 subjects), must be monozygotic twin.
  • Same age-range as probands.
  • Parent and teacher ratings within one SD of population means on ADHD/hyperactivity factors.
  • Consent and assent obtained in writing.

You may not qualify if:

  • ADHD PROBANDS:
  • Presence of other psychiatric disorders that can produce symptoms similar to ADHD (e.g., major depression, bipolar disorder, severe anxiety disorders, pervasive developmental disorders, psychotic disorders, post-traumatic stress disorder).
  • Presence of neuropsychiatric conditions that may confound evaluation of ADHD (e.g., Tourette's syndrome, obsessive-compulsive disorder, or PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcus).
  • Presence of metal objects, pregnancy, or inability to provide a specimen of urine or blood to rule out pregnancy in females over age 12.
  • Presence of alcohol and/or other substance abuse.
  • NORMAL PEDIATRIC VOLUNTEERS:
  • Presence of any psychiatric disorders on structured psychiatric interview (DICA-IV).
  • Presence of known genetic conditions.
  • Presence or history of medical conditions.
  • Presence of metal objects, pregnancy, or inability to provide a specimen to rule out pregnancy in females over age 12.
  • Presence of alcohol and/or other substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Mental Health (NIMH), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Brandt KR, Hattery RR. MRI during pregnancy. Eur Radiol. 1997;7(6):821. doi: 10.1007/s003300050213. No abstract available.

    PMID: 9228095BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

January 18, 2001

First Posted

January 19, 2001

Study Start

January 12, 2001

Study Completion

January 31, 2007

Last Updated

July 2, 2017

Record last verified: 2007-01-31

Locations

US(1)