Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

ADHD Clinical Trial

Official title:

Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT06077669
• Other study ID #: IRB00408678
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: January 2029

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2029
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Drug:
• Methylphenidate
Single oral dose of methylphenidate (5mg or 10 mg)
• Placebo
oral placebo

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal during response inhibition	Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition.	Approximately 90 minutes after dose
Primary	BOLD signal during working memory	BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory	Approximately 90 minutes after dose
Primary	Glutamate level in the anterior cingulate cortex	Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC).	Approximately 2 hours after dose
Primary	Glutamate level in the dorsolateral prefrontal cortex	Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex	Approximately 2 hours after dose
Primary	Cognitive performance as assessed by the Flanker performance task	NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance	Approximately 3 hours after dose
Primary	Working memory performance	NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance	Approximately 3 hours after dose
Secondary	ADHD as assessed by the Connors 3	Connors 3rd edition ADHD assessment, lower score means less symptoms, typical scores are 40 to 59, above 65 is an elevated score (meaning more concerns than are typically reported)	At each study visit, approximately 3 hours after dose
Secondary	NIH Toolbox Cognitive Battery	Cognition Fluid Composite, Cognition Crystallized Composite, Cognition Total Composite Score, and other individual test scores	Approximately 3 hours after dose
Secondary	Methylphenidate plasma levels	Methylphenidate plasma levels will be drawn before and after brain imaging on each visit	Approximately 90 min and 150 min after dose