Ignite Creation Date:
2024-05-06 @ 3:16 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02247986
Status:
WITHDRAWN
Last Update Posted:
2019-12-03
First Post:
2014-09-20
Brief Title:
Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
Status:
WITHDRAWN
Status Verified Date:
2015-05-18
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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 andor 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
Detailed Description:
OBJECTIVE
To determine the impact as indexed by BOLD response of the administration of dopaminergic agonist methylphenidate on the pathophysiology of CDODD
STUDY POPULATION
Youth with CDODD and typically developing TD youth
DESIGN
The study will involve a 2 session design methylphenidate MPH vs placebo Patients with CDODD 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 CDODD 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 CDODD
STUDY POPULATION
Youth with CDODD and typically developing TD youth
DESIGN
The study will involve a 2 session design methylphenidate MPH vs placebo Patients with CDODD 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 CDODD 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14-M-0193 | None | None | None |