Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

NCT ID: NCT06077669

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2029-01-31

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Methylphenidate - low dose

5 mg of methylphenidate

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

Single oral dose of methylphenidate (5mg or 10 mg)

Methylphenidate - high dose

10 mg of methylphenidate

Group Type: EXPERIMENTAL

Methylphenidate

Intervention Type: DRUG

Single oral dose of methylphenidate (5mg or 10 mg)

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

oral placebo

Interventions

Methylphenidate

Single oral dose of methylphenidate (5mg or 10 mg)

Intervention Type: DRUG

Placebo

oral placebo

Intervention Type: DRUG

Other Intervention Names

Ritalin

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Bigos, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00408678

Identifier Type: -

Identifier Source: org_study_id