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Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06077669
Collaborator
(none)
80
Enrollment
1
Location
3
Arms
61
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2028
Anticipated Study Completion Date :
Jan 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Methylphenidate - low dose

5 mg of methylphenidate

Drug: Methylphenidate
Single oral dose of methylphenidate (5mg or 10 mg)
Other Names:
  • Ritalin

    		•
    Experimental: Methylphenidate - high dose

    10 mg of methylphenidate

    Drug: Methylphenidate
    Single oral dose of methylphenidate (5mg or 10 mg)
    Other Names:
  • Ritalin

    		•
    Placebo Comparator: Placebo

    placebo

    Drug: Placebo
    oral placebo

    Outcome Measures

    Primary Outcome Measures

    1. BOLD signal during response inhibition [Approximately 90 minutes after dose]

      Blood oxygenation level dependent (BOLD) signal (brain activity during functional magnetic resonance imaging (fMRI), arbitrary units) in the anterior cingulate cortex during response inhibition.

    2. BOLD signal during working memory [Approximately 90 minutes after dose]

      BOLD signal (brain activity during fMRI, arbitrary units) in the frontal cortex during working memory

    3. Glutamate level in the anterior cingulate cortex [Approximately 2 hours after dose]

      Glutamate level (measured by magnetic resonance spectroscopy (MRS), institutional units) in the anterior cingulate cortex (ACC).

    4. Glutamate level in the dorsolateral prefrontal cortex [Approximately 2 hours after dose]

      Glutamate level (measured by MRS, institutional units) in the dorsolateral prefrontal cortex

    5. Cognitive performance as assessed by the Flanker performance task [Approximately 3 hours after dose]

      NIH Toolbox Cognitive Battery Flanker task, score range 0 to 20, higher score is better performance

    6. Working memory performance [Approximately 3 hours after dose]

      NIH Toolbox Cognitive Battery working memory task (list sorting), score range 0 to 26, higher score is better performance

    Secondary Outcome Measures

    1. ADHD as assessed by the Connors 3 [At each study visit, approximately 3 hours after dose]

      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)

    2. NIH Toolbox Cognitive Battery [Approximately 3 hours after dose]

      Cognition Fluid Composite, Cognition Crystallized Composite, Cognition Total Composite Score, and other individual test scores

    3. Methylphenidate plasma levels [Approximately 90 min and 150 min after dose]

      Methylphenidate plasma levels will be drawn before and after brain imaging on each visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins School of Medicine Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Kristin Bigos, PhD, Johns Hopkins School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT06077669
    Other Study ID Numbers:
    • IRB00408678
    First Posted:
    Oct 11, 2023
    Last Update Posted:
    Oct 11, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Methylphenidate

    Study Results

    No Results Posted as of Oct 11, 2023