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

Sponsor

Johns Hopkins University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04781972

Collaborator

(none)

Enrollment

Location

Arms

21.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
ADHD - Combined Type	Drug: Methylphenidate Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.This is a double-blind cross over of a single dose of methylphenidate (10mg or 15mg) and matching placebo.

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Jul 27, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Methylphenidate first Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.	Drug: Methylphenidate single dose of 10 mg or 15 mg Drug: Placebo Matching placebo
Placebo Comparator: Placebo first Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.	Drug: Methylphenidate single dose of 10 mg or 15 mg Drug: Placebo Matching placebo

Arm

Intervention/Treatment

Experimental: Methylphenidate first

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

Drug: Methylphenidate

single dose of 10 mg or 15 mg

Drug: Placebo

Matching placebo

Placebo Comparator: Placebo first

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

Drug: Methylphenidate

single dose of 10 mg or 15 mg

Drug: Placebo

Matching placebo

Outcome Measures

Primary Outcome Measures

BOLD signal during response inhibition [Approximately 90 minutes after dose]
BOLD signal (brain activity during fMRI, arbitrary units) in the anterior cingulate cortex during response inhibition.
Glutamate level in the anterior cingulate cortex [Approximately 2 hours after dose]
Glutamate level (measured by MRS, institutional units) in the anterior cingulate cortex.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator: Kristin L 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:

NCT04781972

Other Study ID Numbers:

IRB00276357

First Posted:

Mar 4, 2021

Last Update Posted:

May 13, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Methylphenidate

Study Results

No Results Posted as of May 13, 2022