Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 7/11/2015 |
| Start Date: | September 2014 |
| End Date: | August 2018 |
| Contact: | Soonjo Hwang, M.D. |
| Email: | soonjo.hwang@nih.gov |
| Phone: | (301) 451-8442 |
Background:
- Disruptive behavior is a common problem for children and adolescents. It can be treated
with some success with stimulant medicine. Researchers want to learn more about how this
works.
Objective:
- To learn how the brain changes when taking the medicine methylphenidate for behavior
problems.
Eligibility:
- Children ages 10 17 with conduct disorder and/or attention deficit disorder.
- Healthy volunteers the same age.
Design:
- Participants will be screened under a separate protocol.
- Participants will have two 3-hour sessions at the clinic. Girls who are menstruating
will have a pregnancy test before their scans.
- Visit 1: All participants will:
- Perform simple tests on a computer.
- Fill out a questionnaire along with their parent or guardian.
- Have an MRI scan. A magnetic field and radio waves take pictures of the brain.
Participants will lie on a table that slides into a metal cylinder. A coil will be
placed over their head. They will be in the scanner for 60 minutes, lying still or
performing a simple task. They will practice the task before the scan. A computer
screen will show them task information during the scan. The scanner makes loud knocking
sounds. Participants will get earplugs. Their parent or guardian can stay with them
during the scan.
- Only participants with behavior disorders will:
- Take a pill of the study medicine or placebo.
- Be monitored for any side effects.
- Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get
the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.
- Disruptive behavior is a common problem for children and adolescents. It can be treated
with some success with stimulant medicine. Researchers want to learn more about how this
works.
Objective:
- To learn how the brain changes when taking the medicine methylphenidate for behavior
problems.
Eligibility:
- Children ages 10 17 with conduct disorder and/or attention deficit disorder.
- Healthy volunteers the same age.
Design:
- Participants will be screened under a separate protocol.
- Participants will have two 3-hour sessions at the clinic. Girls who are menstruating
will have a pregnancy test before their scans.
- Visit 1: All participants will:
- Perform simple tests on a computer.
- Fill out a questionnaire along with their parent or guardian.
- Have an MRI scan. A magnetic field and radio waves take pictures of the brain.
Participants will lie on a table that slides into a metal cylinder. A coil will be
placed over their head. They will be in the scanner for 60 minutes, lying still or
performing a simple task. They will practice the task before the scan. A computer
screen will show them task information during the scan. The scanner makes loud knocking
sounds. Participants will get earplugs. Their parent or guardian can stay with them
during the scan.
- Only participants with behavior disorders will:
- Take a pill of the study medicine or placebo.
- Be monitored for any side effects.
- Visit 2 is a repeat of Visit 1, except participants who got a pill in Visit 1 will get
the other pill in Visit 2. For healthy volunteers, the 2 visits are exactly the same.
OBJECTIVE:
To determine the impact, as indexed by BOLD response, of the administration of dopaminergic
agonist (methylphenidate) on the pathophysiology of CD/ODD.
STUDY POPULATION:
Youth with CD/ODD and typically developing (TD) youth.
DESIGN:
The study will involve a 2 session design (methylphenidate [MPH] vs. placebo). Patients with
CD/ODD will participate in both sessions. TD youth will be tested for 2 sessions (no
medication) to provide an index of typical task response. Activity within regions of
interest identified from the TD youth will be used to determine whether MPH reduces
differences in BOLD response in CD/ODD relative to TD youth. ICU scores and current ADHD
symptomatology will be used as covariates to determine whether these variables moderate the
putative increase in BOLD response in target regions in the patients with CD.
OUTCOME MEASURES:
Principle dependent measures will be BOLD responses as measured through core tasks.
To determine the impact, as indexed by BOLD response, of the administration of dopaminergic
agonist (methylphenidate) on the pathophysiology of CD/ODD.
STUDY POPULATION:
Youth with CD/ODD and typically developing (TD) youth.
DESIGN:
The study will involve a 2 session design (methylphenidate [MPH] vs. placebo). Patients with
CD/ODD will participate in both sessions. TD youth will be tested for 2 sessions (no
medication) to provide an index of typical task response. Activity within regions of
interest identified from the TD youth will be used to determine whether MPH reduces
differences in BOLD response in CD/ODD relative to TD youth. ICU scores and current ADHD
symptomatology will be used as covariates to determine whether these variables moderate the
putative increase in BOLD response in target regions in the patients with CD.
OUTCOME MEASURES:
Principle dependent measures will be BOLD responses as measured through core tasks.
- INCLUSION CRITERIA
Youth with CD
1. 10-17 years of age.
2. A current diagnosis of CD as determined by the Kiddie-SADS, lifetime version.
- Youth in the CD+comorbid ADHD group will also meet diagnostic criteria for ADHD.
- Youth in the CD without comorbid ADHD group will specifically not meet
diagnostic criteria for ADHD.
3. Youth with CD shouldmust be na(SqrRoot) ve to psychoactive medication (such as:
methylphenidate and amphetamine).
TD youth
1. 10-17 years of age.
2. No current psychiatric diagnosis, as determined by the Kiddie-SADS, lifetime version.
EXCLUSION CRITERIA
Exclusion criteria for youth with CD (with or without ADHD)
1. Comorbid psychotic, major mood, tic, pervasive developmental, and substance abuse
disorders.
2. Presence of comorbid ADHD is exclusory for the group of patients with CD without ADHD
3. History of known structural cardiac abnormalities, cardiomyopathy, serious heart
rhythm abnormalities, coronary artery disease, or other serious cardiac problems
4. Current weight less than 25kg or over 90kg
Exclusion criteria for all participants (CD with ADHD, CD without ADHD and TD)
1. History of serious CNS disease disorder (examples aresuch as: history of seizure,
epilepsy, brain tumor, brain hemorrhage, and major CNS infection such as meningitis
or encephalitis)
2. Previous history of known structural cardiac abnormalities, cardiomyopathy, serious
heart rhythm abnormalities, coronary artery disease, or other serious cardiac
problems
3. Current use of any psychiatric medications and centrally acting medications (such as
stimulants, non-stimulant ADHD medications, antidepressants, anxiolytics,
antipsychotics and anti-epilepsy medications), and past history of use of
psychoactive medication (such as methylphenidate and amphetamine)
4. A positive urine pregnancy test
5. A Positive urine toxicology, History/current diagnosis of substance abuse/dependence
6. Suicidal or homicidal ideation within the past 6 months.
7. Wechsler Abbreviated Scale of Intelligence (WASI) (D. Wechsler, 1999) scores < 70
8. Metal in body (i.e., hearing aid, cardiac pacemaker, bone plates, etc),
claustrophobia, or any other condition that would preclude fMRI scanning.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-4000
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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