Status:
WITHDRAWN
Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD
Lead Sponsor:
Johns Hopkins University
Conditions:
ADHD
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
The goal of this proposal is to develop brain imaging tools to measure the effects of methylphenidate in children and adolescents with attention deficit hyperactivity disorder (ADHD). Methylphenidate ...
Eligibility Criteria
Inclusion
- Age 6 to 18 years
- Diagnosis of ADHD
- A score of at least 3 (mildly ill) on the clinician administered Clinical Global Impressions-Severity (CGI-S)
Exclusion
- Currently taking stimulant medications (within one week of first study visit). Patients will not be asked to discontinue any treatments for the purpose of this research study. Subjects will include treatment naïve patients and patients who were previously treated with stimulant medications, but are not currently treated, and meet study criteria.
- Having an adverse reaction to methylphenidate, or other stimulant medication
- Current psychiatric disorder, including bipolar I or II disorder, major depressive, disorder, obsessive-compulsive disorder, autism spectrum disorder, Tourette syndrome, or history of psychosis
- Patient is at risk for clinically significant deterioration due to study protocol, as assessed by primary medical investigator (Dr. Grant)
- Confirmed genetic disorder with cognitive and/or behavioral disturbances
- Active, unstable medical illness that may interfere with cognition or compromises safety of the patient
- History of head trauma with loss of consciousness or any evidence of functional impairment due to, and persisting after, head trauma
- Neurological disorder, mental retardation, intellectual or disability, or other non-ADHD cause of cognitive impairment
- Pregnant or breast-feeding women
- Having a contraindication to MRI, including a pacemaker, defibrillator or other medical implant, other metal objects, or claustrophobia, or for having braces or other metal in the head region (likely to create an artifact on the MRI scans).
- Currently smoking or using controlled or illicit substances, including alcohol.
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2029
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06077669
Start Date
April 16 2024
End Date
January 1 2029
Last Update
March 15 2024
Active Locations (1)
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1
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21287