Clinical trial NCT06077669: Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD
Official title: Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: ADHD
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 is an FDA-approved treatment for ADHD. Specifically, the investigators will correlate brain activity during cognitive tasks and brain chemistry with cognitive performance. These measures could help the investigators understand how current ADHD medications work and then could be used to develop novel drugs to treat ADHD in children and adolescents.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: BOLD signal during response inhibition
timeFrame: Approximately 90 minutes after dose
measure: BOLD signal during working memory
timeFrame: Approximately 90 minutes after dose
measure: Glutamate level in the anterior cingulate cortex
timeFrame: Approximately 2 hours after dose
measure: Glutamate level in the dorsolateral prefrontal cortex
timeFrame: Approximately 2 hours after dose
measure: Cognitive performance as assessed by the Flanker performance task
timeFrame: Approximately 3 hours after dose
measure: Working memory performance
timeFrame: Approximately 3 hours after dose
Secondary outcomes:
measure: ADHD as assessed by the Connors 3
timeFrame: At each study visit, approximately 3 hours after dose
measure: NIH Toolbox Cognitive Battery
timeFrame: Approximately 3 hours after dose
measure: Methylphenidate plasma levels
timeFrame: Approximately 90 min and 150 min after dose
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Kristin Bigos, PhD
role: PRINCIPAL_INVESTIGATOR
References: