Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

Last updated: March 13, 2024
Sponsor: Johns Hopkins University
Overall Status: Trial Not Available

Phase

4

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

Placebo

Methylphenidate

Clinical Study ID

NCT06077669
IRB00408678
  • Ages 6-18
  • All Genders

Study 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

Inclusion Criteria:

  • Age 6 to 18 years
  • Diagnosis of ADHD
  • A score of at least 3 (mildly ill) on the clinician administered Clinical GlobalImpressions-Severity (CGI-S)

Exclusion

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 thisresearch study. Subjects will include treatment naïve patients and patients who werepreviously treated with stimulant medications, but are not currently treated, and meetstudy 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, asassessed 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 compromisessafety of the patient
  • History of head trauma with loss of consciousness or any evidence of functionalimpairment due to, and persisting after, head trauma
  • Neurological disorder, mental retardation, intellectual or disability, or othernon-ADHD cause of cognitive impairment
  • Pregnant or breast-feeding women
  • Having a contraindication to MRI, including a pacemaker, defibrillator or othermedical implant, other metal objects, or claustrophobia, or for having braces or othermetal in the head region (likely to create an artifact on the MRI scans).
  • Currently smoking or using controlled or illicit substances, including alcohol.

Study Design

Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
April 16, 2024
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Johns Hopkins School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

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