Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD

Johns Hopkins University

Status and phase: Enrolling; Phase 4

Conditions: ADHD - Combined Type

Treatments: Drug: Methylphenidate; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04781972

IRB00276357

Details and patient eligibility

About

The investigators' goal is to develop neuroimaging biomarkers to predict response to treatment with methylphenidate, which then can be used in the development of novel pharmacological treatments for attention-deficit/hyperactivity disorder (ADHD). The overall objective of this study is to measure the changes in task-related neural activity related to symptoms of ADHD (measured by functional MRI) and brain glutamate levels (measured by magnetic resonance spectroscopy, MRS) after treatment with methylphenidate (MPH). This will be a double-blind crossover of methylphenidate and placebo in adults with ADHD. Participants will complete neuropsychological testing along with fMRI and MRS scans after a single dose of each treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• right handed

Exclusion criteria

• pregnant or breast feeding
• past or current neurological disorder
• non-ADHD cause of cognitive impairment
• uncontrolled medical disorder
• head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
• having an adverse reaction to methylphenidate, or other stimulant medication
• having a contraindication to MRI
• current smoking

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Methylphenidate first

Experimental group

Description:

Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.

Treatment:

Drug: Placebo

Drug: Methylphenidate

Placebo first

Placebo Comparator group

Description:

Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.

Treatment:

Drug: Placebo

Drug: Methylphenidate