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Central Nervous System Stimulant

Methylphenidate for ADHD

Phase 4
Recruiting
Led By Kristin L Bigos, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 90 minutes after dose
Awards & highlights

Study Summary

This trial is looking at using brain scans to predict how well someone with ADHD will respond to treatment with methylphenidate, and to measure the changes in task-related neural activity and brain glutamate levels after treatment.

Who is the study for?
This trial is for right-handed adults with ADHD who can undergo MRI scans. It's not suitable for those with cognitive issues not due to ADHD, contraindications to MRI, pregnancy, breastfeeding, current smokers, history of bad reactions to stimulants like methylphenidate, uncontrolled medical conditions or past/current neurological disorders.Check my eligibility
What is being tested?
The study tests the brain's response to Methylphenidate (a common ADHD medication) versus a placebo. Participants will receive both treatments at different times in a random order and undergo brain imaging (fMRI and MRS) along with neuropsychological testing after each dose.See study design
What are the potential side effects?
Methylphenidate may cause side effects such as nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea or vomiting. However specific side effects related to this trial are not listed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 90 minutes after dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 90 minutes after dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BOLD signal during response inhibition
Glutamate level in the anterior cingulate cortex

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908
51%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Worried/Anxious
21%
Dull, tired, listless
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 - Placebo First
Phase 1-Medication First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methylphenidate firstExperimental Treatment2 Interventions
Single oral dose of methylphenidate (10mg or 15 mg) and then matching placebo after washout period of one week.
Group II: Placebo firstPlacebo Group2 Interventions
Matching placebo and then single oral dose of methylphenidate (10mg or 15 mg) after washout period of one week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Methylphenidate
2014
Completed Phase 4
~431850

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,134 Total Patients Enrolled
3 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,351 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Kristin L Bigos, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Media Library

Methylphenidate (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT04781972 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Placebo first, Methylphenidate first
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT04781972 — Phase 4
Methylphenidate (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04781972 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT04781972 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I have the required prerequisites to be included in this experiment?

"To qualify for this study, applicants must have an ADHD diagnosis and be between 18 to 40 years old. This trial is accepting up to 30 participants in total."

Answered by AI

What is the maximum capacity for enrollees to this research project?

"Indeed, clinicaltrials.gov's data confirms that this medical experiment is presently seeking participants, having been first published on July 27th 2021 and last updated on October 6th 2022. The trial seeks to enrol 30 individuals from one centre."

Answered by AI

Are individuals of a younger age able to participate in this experiment?

"Participants of this trial must be between the age brackets of 18 and 40. For those outside these ages, there are 15 trials for minors aged under 18 and 13 studies accommodating patients over 65 years old."

Answered by AI

Has there been any other research involving Methylphenidate prior to this current trial?

"At present, there are 29 clinical trials investigating the efficacy of Methylphenidate with two studies in Phase 3. Most research centres for this medication can be found in Lexington, Kentucky; however, 42 different sites across the nation have active trials for it."

Answered by AI

Is participation in this research available to the public?

"Affirmative. According to clinicaltrials.gov, this ongoing study is calling for volunteers and was initially posted on the 27th July 2021 with its most recent edit taking place on October 6th 2022. Currently, 30 participants are needed at a single research facility."

Answered by AI

Has Methylphenidate been certified by the FDA?

"The safety of Methylphenidate is rated 3, as this drug has already been approved and the current trial is in its fourth phase."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
Maryland
California
Other
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

money and be fixed. I have try alot of different medications but nothing really works for me.
PatientReceived 1 prior treatment
I was female diagnosed as an adult during the pandemic. I want to understand more about how best to treat this disorder, and so much of the research is about children.
PatientReceived no prior treatments
I struggle with my ADHD symptoms. I'm starting law school in the fall, so I really want to figure out a way to manage my symptoms so that I can be successful in school.
PatientReceived 1 prior treatment
I do not have insurance and I have been looking for a way to take care of my ADHD for years. My current dr is only $50 a month but does not prescribe controlled substances like my adhd medication. I’ve been with her for almost 10 years and my quality of life has fallen apart and COVID didn’t help. I was enrolled in school and my focus made every day a battle of crying and melt downs trying to study until I had to quit due to stress.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Johns Hopkins School of Medicine: < 24 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD
2021. "Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04781972.
All > Adhd
~0 spots leftby May 2024
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