Methylphenidate for Attention Deficit Hyperactivity Disorder (ADHD)

Johns Hopkins School of Medicine, Baltimore, MD
Attention Deficit Hyperactivity Disorder (ADHD)Methylphenidate - Drug
18 - 40
All Sexes
What conditions do you have?

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.

Video Summary

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Approximately 90 minutes after dose

Hour 2
Glutamate level in the anterior cingulate cortex
Approximately 90 minutes after dose
BOLD signal during response inhibition

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

Phase 1-Medication First
51%Appetite Loss
29%Picking at skin, nailbiting
21%Dull, tired, listless
19%Tearful, depressed
13%Motor Tics
12%Buccal-lingual movements
10%Social Withdrawal
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02039908) in the Phase 1-Medication First ARM group. Side effects include: Appetite Loss with 51%, Insomnia with 40%, Irritability with 33%, Picking at skin, nailbiting with 29%, Dull, tired, listless with 21%.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Methylphenidate first
1 of 2
Placebo first
1 of 2

Experimental Treatment

Non-Treatment Group

30 Total Participants · 2 Treatment Groups

Primary Treatment: Methylphenidate · Has Placebo Group · Phase 4

Methylphenidate firstExperimental Group · 2 Interventions: Placebo, Methylphenidate · Intervention Types: Drug, Drug
Placebo firstPlaceboComparator Group · 2 Interventions: Placebo, Methylphenidate · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 3
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 90 minutes after dose

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,115 Previous Clinical Trials
32,578,739 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,111 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Kristin L Bigos, PhDPrincipal InvestigatorJohns Hopkins School of Medicine

Eligibility Criteria

Age 18 - 40 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are right-handed.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Johns Hopkins School of Medicine100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria41.2%
Met criteria58.8%
Why did patients apply to this trial?
  • "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."
  • "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."
How many prior treatments have patients received?

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Johns Hopkins School of Medicine: < 24 hours
Typically responds via

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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

"Indeed,'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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is participation in this research available to the public?

"Affirmative. According to, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.