Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
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|ClinicalTrials.gov Identifier: NCT02247986|
Recruitment Status : Withdrawn
First Posted : September 25, 2014
Last Update Posted : December 3, 2019
- 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.
- To learn how the brain changes when taking the medicine methylphenidate for behavior problems.
- Children ages 10 17 with conduct disorder and/or attention deficit disorder.
- Healthy volunteers the same age.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Conduct Disorder Attention Defict Hyperactivity Disorder||Drug: Methylphenidate Hydrochloride||Phase 1 Phase 2|
To determine the impact, as indexed by BOLD response, of the administration of dopaminergic agonist (methylphenidate) on the pathophysiology of CD/ODD.
Youth with CD/ODD and typically developing (TD) youth.
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.
Principle dependent measures will be BOLD responses as measured through core tasks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder|
|Study Start Date :||September 4, 2014|
|Actual Primary Completion Date :||May 18, 2015|
|Actual Study Completion Date :||May 18, 2015|
- Drug: Methylphenidate Hydrochloride
Bold signal changes by methylphenidate on DBD
- Patients with CD will show an increase in the amygdala response to fearful expressions such that the difference between BOLD response in patients and TDs is reduced on MPH relative to placebo. ICU score will be a significant covariate of the inc... [ Time Frame: 2 years from the initiation of the protocol ]
- Patients with CD will show an increase in reward prediction errors and reward expected value signaling within striatum and ventromedial frontal cortex (vmPFC) such that the difference between BOLD response in patients and TDs is reduced on MPH r... [ Time Frame: 2 years from the initiation of the protocol ]
- Patients with CD will show an increase in conflict related signaling within dorsomedial, lateral and parietal cortices such that the difference between BOLD response in patients and TDs is reduced on MPH relative to placebo. Current ADHD sympto... [ Time Frame: 2 years from the initiation of the protocol ]
- Symptom profiles measured by the clinical scales listed in the protocol (CBCL, the ICU, Connor s parent report on ADHD symptom) will be significantly related to the BOLD signal changes after methylphenidate administration. [ Time Frame: 2 years from the initiation of the protocol ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247986
|Principal Investigator:||James J Blair, Ph.D.||National Institute of Mental Health (NIMH)|