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Investigating the Neuro-Cognitive Underpinnings of the Emotional Dysfunction Linked to Childhood Behavioral Disturbance
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
05-M-0105 |
Sponsoring Institute |
National Institute of Mental Health (NIMH) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
None |
Special Instructions |
Currently Not Provided |
Keywords |
Amygdala; |
Recruitment Keyword(s) |
Attention Deficit Hyperactivity Disorder; |
Condition(s) |
Attention Deficit Disorder with Hyperactivity; |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
This study will examine brain activity in children age 10-18 with disruptive behavior problems, including conduct disorder (CD), oppositional defiant disorder (ODD), and attention deficit hyperactivity disorder (ADHD), compared with children without behavioral problems. Our goal is to examine differences in how emotions, social situations, and problem-solving situations are processed in the brain across these groups of children.
Eligibility
INCLUSION CRITERIA:
1. Individuals with CD + CU: Male and female subjects aged 8-18 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.
2. Individuals with CD-CU: Male and female subjects aged 8 -18 who score less than 20 on the APSD/PCL-YV. Children with antisocial behavioral problems on medications with psychotopic 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 Starattera (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.
3.Individuals with ADHD: Male and female subjects aged 8-18 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 > 65 on the hyperactivity-impulsivity subscale of the Connors Teacher Scale. Participants in this group will have APSD scores < 20.
4. Comparison individuals: Male and female subjects aged 8-18 who are free from any current or past psychopathology (all will score less than 20 on the APSD/PCL-YV).
5. 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:
1. I.Q.< 80.
2. Ongoing medical illness other than those listed in the inclusion criteria for the respective groups that require use of any medication that may have psychotropic effects. For example, a patient with history of mild asthma that did not require medication may be included, however a patient with asthma requiring use of beta blockers, steroids, etc. would not be included. For children with ADHD or healthy volunteer children, a contraindication to discontinuing medication for 48 hours. Only simple stimulant medications will be held for 48 hours. These include methylphenidate, amphetamine and their derivative 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), or modafinil (Provigil) are not safe to stop suddenly and children with ADHD taking these medications will not be included.
3. Subjects with psychopathic tendencies who receive a diagnosis of an anxiety or mood disorder as determined by a clinical and K-SAD review conducted by a psychiatrist will be excluded. Additionally, children with active psychosis, pervasive developmental disorders or Tourette's syndrome will be excluded.
4.Children with CD-CU will be evaluated through the KSAD and clinical review by a psychiatrist. Explicit exclusions include active psychosis, Pervasive Developmental Disorders and Tourette's syndrome. Children with anxiety disorders will be included given the high comorbidity of CD-CU and anxiety disorders.
5. Individuals with ADHD will be evaluated through the KSAD and clinical review by a psychiatrist. Those children who receive diagnosis of mood disorders through this evaluation process will be excluded. Additional explicit exclusions include active psychosis, Pervasive Developmental Disorders and Tourette's syndrome. Children with anxiety disorders will be included given the high comorbidity of ADHD and anxiety disorders.
6. Any other psychiatric disorder that is sufficiently severe to require specific treatment, with the exception of those listed in the inclusion criteria for the respective groups.
7. Neurologic disorder (including seizures).
8. Any metallic objects in the body. Metal plates, certain types of dental braces, cardiac pacemakers, etc., that are sensitive to electromagnetic fields contraindicate MRI scans.
9. Claustrophobia: participants will be questioned about potential discomfort in being in an enclosed space, such as an MRI scanner.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information http://clinicalstudies.info.nih.gov. |
| James J. Blair, Ph.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room 2-5330 10 Center Drive Bethesda, Maryland 20892 (301) 496-6120 PeterSchmidt@mail.nih.gov |
James J. Blair, Ph.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 10 Room 2-5330 10 Center Drive Bethesda, Maryland 20892 (301) 496-6120 PeterSchmidt@mail.nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00104039
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