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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00104039 |
This study will examine brain changes in children and adolescents with behavioral problems and compare them to children and adolescents without behavioral problems.
Children between 8 and 17 years of age with attention deficit hyperactivity disorder (ADHD) or anti-social behavior or who are healthy normal volunteers may be eligible for this study. Candidates are screened with a medical history and physical examination, mental health and psychiatric interviews, blood test, and urine drug screen. Children who are taking atomoxetine (Stattera), bupropion (Wellbutrin), modafinil (Provigil), or similar medications for behavioral problems are excluded.
Participants have the following procedures over two separate visits:
Participants may be invited to participate in a genetics study and a study of fatty acids in the blood.
Condition |
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Attention Deficit Disorder With Hyperactivity Mental Disorders Diagnosed in Childhood |
Study Type: | Observational |
Official Title: | Investigating the Neuro-Cognitive Underpinnings of the Emotional Dysfunction Linked to Childhood Behavioral Disturbance |
Estimated Enrollment: | 480 |
Study Start Date: | February 2005 |
OBJECTIVE:
The goal of this protocol is to investigate the neuro-cognitive underpinnings of the emotional dysfunction linked to childhood behavioral disturbance; in particular, psychopathic tendencies but also ADHD. The functional hypotheses that we are testing with both neuro-cognitive and neuro-imaging paradigms are that: (1) psychopathic tendencies, but not ADHD, are associated with dysfunction in the formation and operational use of stimulus-punishment and, to a lesser extent, stimulus-reward association information; and (2) that ADHD, but not psychopathic tendencies, is associated with impairment in executive systems related to the representation and execution of task demands.
STUDY POPULATION:
160 Children with psychopathic tendencies; 160 children with ADHD; and 160 healthy volunteer children. All Children will be between the ages of 10 and 17. Both males and females will be enrolled.
DESIGN:
The current study will have three phases: i) participant screening (up to 3 hours); ii) neuropsychological assessment and training in an MRI simulator (up to 4 hours); iii) The MRI scanning session (up to 2 hours, no more than 90 minutes in scanner). Participants, if they are willing, may be invited to participate in more than one scanning session (up to a maximum of 3 120 minute sessions) or neurocognitive testing session.
OUTCOME MEASURES:
Behaviorally, we predict that children with psychopathic tendencies will present with impairment on tasks that involve either the formation or operational use of particular stimulus-punishment associations (e.g., the subjective value learning task and emotional interrupt task). In contrast, we predict that children with ADHD, but no indications of psychopathic tendencies, will show no behavioral impairment on such tasks. However, we predict that children with ADHD will present with impairments on executive function tasks (e.g., the Number Stroop paradigm). In contrast, we predict that children with psychopathic tendencies will show no impairment on these tasks. At the anatomical level, we anticipate reduced activation of emotional related systems in children with psychopathic tendencies during response selection and emotional impact tasks (in particular, reduced activation of the amygdala, regions of orbitofrontal cortex and anterior cingulate). We anticipate that the neural response of children with ADHD during these tasks will be less anomalous. We anticipate that the neural response of children with ADHD during the performance of response control tasks to be anomalous (with considerable greater recruitment of anterior and posterior compensatory systems).
Ages Eligible for Study: | 8 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
INCLUSION CRITERIA:
Individuals with psychopathic tendencies: Male and female subjects aged 8-17 who score equal to or more than 20 on the APSD/PCL-YV.
Children with antisocial behavioral problems on medications with psychotropic effects will be considered if their target behaviors persist despite the use of medications. In these children, only simple stimulant medications will be held for 48 hours. These include methylphenidate, amphetamine and their derivatives including Ritalin, Ritalin SR, Ritalin LA, Methylin, Methlin ER, Metadate CD, Concerta, Dexedrine, Dextrostat, Dexedrine Spansule, Adderall, Adderall XR, and Focalin. Medications like Strattera (atomoxetine), bupropion (Wellbutrin), modafinil (Provigil), or valproic acid (Depakote), or other mood stabilizers are not safe to stop suddenly and children taking these medications will not be asked to stop them.
EXCLUSION CRITERIA:
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 050105, 05-M-0105 |
Study First Received: | February 19, 2005 |
Last Updated: | July 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00104039 |
Health Authority: | United States: Federal Government |
Amygdala Orbital Frontal Cortex Serotonin Orbitofrontal Cortex Attention Deficit Hyperactivity Disorder |
ADHD Anti-Social Behavior Healthy Volunteer HV |
Signs and Symptoms Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood Neurologic Manifestations |
Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Healthy Dyskinesias Serotonin |
Pathologic Processes Disease Nervous System Diseases |