- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00026546
Behavior in Children With Attention Deficit Hyperactivity Disorder and in Healthy Volunteers
A Behavioral and Functional Neuroimaging Study of Inhibitory Motor Control
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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Maryland
-
Bethesda, Maryland, Verenigde Staten, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
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:
I.Q. less than 80; pregnancy; ongoing medical illness or neurological disorder other than ADHD; contraindication to discontinuing medication for 72 hours; any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of Oppositional Defiant Disorder, and the Learning, Communication, and Elimination Disorders, Separation Anxiety Disorder or Social Anxiety Disorder. Explicit exclusions include Pervasive Developmental Disorders, Tourette's syndrome, conduct disorder, and mood or Generalized anxiety disorders.
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Medewerkers en onderzoekers
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 020036
- 02-M-0036
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .