Multimodal Brain Imaging of Methylphenidate in Children and Adolescents With ADHD

Johns Hopkins University

Status and phase: Withdrawn; Phase 4

Conditions: ADHD

Treatments: Drug: Methylphenidate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06077669

IRB00408678

Details and patient eligibility

About

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.

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Methylphenidate - low dose

Experimental group

Description:

5 mg of methylphenidate

Treatment:

Drug: Methylphenidate

Methylphenidate - high dose

Experimental group

Description:

10 mg of methylphenidate

Treatment:

Drug: Methylphenidate

Placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo