NCT00026546

Brief Summary

The purpose of this study is to determine how the brain controls motor activity in children with attention deficit hyperactivity disorder (ADHD). The inability to control one s behavior is an important symptom of many psychiatric illnesses. The stop signal paradigm which involves withholding a motor response to a go signal, has proved useful in assessing uncontrolled behavior in children with ADHD and other disorders. This study will use a stop signal paradigm in order to evaluate the ability of children with and without ADHD to control their motor behavior. A magnetic resonance imaging (MRI) scan will be used to study how the brain works during specific activities. This study will evaluate the stop signal paradigm in three groups of people: healthy children, children with ADHD, and healthy adults. This study comprises two sub-studies: a behavioral study in which participants perform simple activities and an MRI study. Participants will be asked to stop any over-the-counter medication 5 days before entering the behavioral or MRI study. Children with ADHD will be asked to stop taking medication for ADHD 72 hours before the study. All participants will have a medical history and a psychiatric evaluation (for children, both parents and children provide information for the assessment). Participants in the MRI study will also have physical examinations and blood and urine tests. All children will undergo intelligence tests; and those with ADHD will have tests to confirm the diagnosis. The parents of child participants will complete an autism screening questionnaire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 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

November 7, 2001

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 12, 2001

Completed
16.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2018

Completed
Last Updated

December 12, 2019

Status Verified

October 9, 2018

First QC Date

November 9, 2001

Last Update Submit

December 11, 2019

Conditions

Keywords

Stop TaskFunctional (BOLD) MRIDevelopmentalInhibitory ControlAttention Deficit Hyperactivity DisorderADHDImpulsivityHealthy VolunteerNormal VolunteerHV

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • CONTROL SUBJECTS:
  • Male and female subjects in two age cohorts will be recruited: 7-16 and 18-45 years. Subjects must be free from any current or past psychopathology and be medication-free. The 7-16 year olds will be gender matched to the ADHD subjects.
  • ADHD SUBJECTS:
  • Male and female subjects aged 7-16 who currently meet DSM-IV criteria for ADHD. The diagnosis will be made on the basis of a K-SADS-PL interview with the parent and a t score greater than 65 on the hyperactivity-impulsivity subscale of the Connors Teacher Scale. With the exception of symptoms and signs attributable to the ADHD, Oppositional Defiant Disorder, the Learning, Communication Disorders, Elimination Disorders, and Separation or Social Anxiety Disorders, subjects must be free from any current or past psychopathology.
  • fMRI STUDY:
  • Subjects aged 8-45 years will be recruited. Otherwise the same as for the behavioral study above for healthy volunteers and ADHD participants.

You may not qualify if:

  • CONTROL SUBJECTS:
  • I.Q. less than 80; pregnancy ; ongoing medical illness; neurological disorder (including seizures); meeting past or present criteria for any diagnosis on the K-SADS-PL (children and adolescents) or SCID (adults).
  • ADHD SUBJECTS:
  • fMRI STUDY:
  • I.Q. less than 80; pregnancy; ongoing medical illness; neurological disorder (including seizures); meeting past or present criteria for any diagnosis on SCID; or KSADS except for ADHD, Oppositional Defiant Disorder, the Learning, Communication Disorders, Elimination Disorders, and Separation or Social Anxiety Disorders; any metallic objects in the body that would constitute a contraindication to an fMRI scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Oosterlaan J, Logan GD, Sergeant JA. Response inhibition in AD/HD, CD, comorbid AD/HD + CD, anxious, and control children: a meta-analysis of studies with the stop task. J Child Psychol Psychiatry. 1998 Mar;39(3):411-25.

    PMID: 9670096BACKGROUND
  • Casey BJ, Giedd JN, Thomas KM. Structural and functional brain development and its relation to cognitive development. Biol Psychol. 2000 Oct;54(1-3):241-57. doi: 10.1016/s0301-0511(00)00058-2.

    PMID: 11035225BACKGROUND
  • Alexander GE, Crutcher MD, DeLong MR. Basal ganglia-thalamocortical circuits: parallel substrates for motor, oculomotor, "prefrontal" and "limbic" functions. Prog Brain Res. 1990;85:119-46.

    PMID: 2094891BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityImpulsive Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Ellen Leibenluft, M.D.

    National Institute of Mental Health (NIMH)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2001

First Posted

November 12, 2001

Study Start

November 7, 2001

Study Completion

October 9, 2018

Last Updated

December 12, 2019

Record last verified: 2018-10-09

Locations