30 Participants Needed

Methylphenidate for ADHD

KL
RW
Overseen ByRobyn Wiseman, BS
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: Johns Hopkins University
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

This trial studies how methylphenidate affects brain activity and chemicals in adults with ADHD using brain scans. The goal is to develop better treatments for ADHD. Methylphenidate is the most common treatment for attention deficit hyperactivity disorder (ADHD) and has been shown to improve attention and behaviour.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What evidence supports the effectiveness of the drug Methylphenidate for treating ADHD?

Research shows that controlled-delivery methylphenidate, like Metadate CD, is effective in reducing ADHD symptoms in children and adolescents, performing better than a placebo and similarly to immediate-release versions. Additionally, dexmethylphenidate, a form of methylphenidate, has been found effective at managing ADHD symptoms at lower doses.12345

Is methylphenidate generally safe for humans?

Methylphenidate, used in various forms like Ritalin and Concerta, is generally well tolerated in treating ADHD in children and adults. Most reported side effects are mild and resolve quickly, but long-term effects are still being studied.16789

How is the drug Methylphenidate unique in treating ADHD?

Methylphenidate, especially in its controlled-delivery form (like Metadate CD), is unique because it provides effective symptom control throughout the school day with just one dose, making it convenient for children and adolescents with ADHD. It is also well-tolerated and can be used alongside behavioral and psychosocial interventions.134610

Research Team

KL

Kristin L Bigos, PhD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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.

Inclusion Criteria

You must be right-handed.

Exclusion Criteria

having a contraindication to MRI
I have a history of neurological disorders.
I have had a head injury with unconsciousness or lasting problems in the past year.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single oral dose of methylphenidate or placebo, followed by neuropsychological testing and fMRI/MRS scans

1 day per treatment session
2 visits (in-person)

Washout

A washout period of one week between treatments to clear the previous dose

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Methylphenidate
  • Placebo
Trial OverviewThe 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.
Participant Groups
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.

Methylphenidate is already approved in United States, Canada, European Union for the following indications:

🇺🇸
Approved in United States as Methylphenidate for:
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy
🇨🇦
Approved in Canada as Methylphenidate for:
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy
🇪🇺
Approved in European Union as Methylphenidate for:
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Narcolepsy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

Controlled-delivery methylphenidate (methylphenidate CD) is effective and well tolerated for treating ADHD in children aged 6 and older, showing superior control of symptoms compared to osmotic release methylphenidate during a typical school day.
In clinical trials lasting 3 weeks, methylphenidate CD was found to be more effective than a placebo and equally effective as immediate-release methylphenidate, making it a strong option for managing ADHD symptoms during school hours.
Methylphenidate controlled-delivery capsules (EquasymXL, Metadate CD): a review of its use in the treatment of children and adolescents with attention-deficit hyperactivity disorder.Anderson, VR., Keating, GM.[2018]
In a study involving children aged 6-12 years with ADHD, once-daily modified-release methylphenidate (EqXL) was found to be non-inferior to twice-daily immediate-release methylphenidate (MPH-IR) in reducing ADHD symptoms over three weeks.
Both formulations of methylphenidate were significantly more effective than placebo, and all treatments were well tolerated, indicating a favorable safety profile.
Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention Deficit/Hyperactivity Disorder.Findling, RL., Quinn, D., Hatch, SJ., et al.[2018]
Dexmethylphenidate, a chirally pure form of methylphenidate, has been shown to effectively manage ADHD in children at half the dose of traditional Ritalin, based on clinical trials involving 684 children.
The drug works by inhibiting the reuptake of norepinephrine and dopamine, and has been found to be well tolerated, with ongoing research to further understand its therapeutic action.
Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride.[2018]

References

Methylphenidate controlled-delivery capsules (EquasymXL, Metadate CD): a review of its use in the treatment of children and adolescents with attention-deficit hyperactivity disorder. [2018]
Comparison of the clinical efficacy of twice-daily Ritalin and once-daily Equasym XL with placebo in children with Attention Deficit/Hyperactivity Disorder. [2018]
Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride. [2018]
Spotlight on methylphenidate controlled-delivery capsules (Equasym XL, Metadate CD) in the treatment of children and adolescents with attention-deficit hyperactivity disorder. [2019]
Symptom control in children and adolescents with attention-deficit/hyperactivity disorder on switching from immediate-release MPH to OROS MPH Results of a 3-week open-label study. [2022]
A postmarketing clinical experience study of Metadate CD. [2019]
Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. [2022]
[Utilization of methylphenidate(Ritalin) in France]. [2013]
Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results from a small, controlled trial of lisdexamfetamine dimesylate. [2015]
The clinical impact of switching attention deficit hyperactivity disorder patients from OROS(®)-MPH to Novo-MPH ER-C(®): A paediatric practice review. [2021]