Status:
WITHDRAWN
Investigating the Impact of Methylphenidate on Neural Response in Disruptive Behavioral Disorder
Lead Sponsor:
National Institute of Mental Health (NIMH)
Conditions:
Conduct Disorder
Attention Defict Hyperactivity Disorder
Eligibility:
All Genders
10-17 years
Phase:
PHASE1
PHASE2
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. ...
Detailed Description
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/OD...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Youth with CD
- 10-17 years of age.
- 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.
- Youth with CD shouldmust be na(SqrRoot) ve to psychoactive medication (such as: methylphenidate and amphetamine).
- TD youth
- 10-17 years of age.
- No current psychiatric diagnosis, as determined by the Kiddie-SADS, lifetime version.
- EXCLUSION CRITERIA
- Exclusion criteria for youth with CD (with or without ADHD)
- Comorbid psychotic, major mood, tic, pervasive developmental, and substance abuse disorders.
- Presence of comorbid ADHD is exclusory for the group of patients with CD without ADHD
- History of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
- Current weight less than 25kg or over 90kg
- Exclusion criteria for all participants (CD with ADHD, CD without ADHD and TD)
- 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)
- Previous history of known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
- 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)
- A positive urine pregnancy test
- A Positive urine toxicology, History/current diagnosis of substance abuse/dependence
- Suicidal or homicidal ideation within the past 6 months.
- Wechsler Abbreviated Scale of Intelligence (WASI) (D. Wechsler, 1999) scores \<70
- Metal in body (i.e., hearing aid, cardiac pacemaker, bone plates, etc), claustrophobia, or any other condition that would preclude fMRI scanning.
Exclusion
Key Trial Info
Start Date :
September 4 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02247986
Start Date
September 4 2014
End Date
May 18 2015
Last Update
December 3 2019
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