Methylphenidate for ADHD

Overseen By Robyn Wiseman, BS

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Stimulants

Disqualifiers: Pregnancy, Neurological disorder, Smoking, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day per treatment session

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to examine how methylphenidate, a common ADHD medication, affects brain activity and chemistry. Researchers seek to predict treatment response in individuals with ADHD using brain scans. Participants will receive either methylphenidate or a placebo (a "fake" pill with no active medication) and switch after a week. This study is ideal for right-handed adults with ADHD who do not have major medical or neurological disorders. As a Phase 4 trial, this research helps to understand how this FDA-approved and effective treatment benefits more patients.

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 is the safety track record for methylphenidate?

Research shows that methylphenidate (MPH) is generally a safe treatment for ADHD. Evidence indicates that MPH effectively manages symptoms in both children and adults. Most people tolerate it well, though some may experience side effects such as trouble sleeping, loss of appetite, or a faster heartbeat. These side effects are usually mild and manageable.

The FDA has approved methylphenidate for treating ADHD, confirming its safety through thorough testing. Studies have also examined long-term use of MPH and found it safe for extended periods.

Overall, evidence suggests that MPH is a reliable and safe option for treating ADHD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Methylphenidate is unique because it targets the brain's dopamine and norepinephrine pathways, which can improve attention and focus in individuals with ADHD. Unlike other ADHD treatments like amphetamines, methylphenidate is known for its relatively mild side effect profile and shorter duration of action, making it a flexible option for managing symptoms. Researchers are excited about its potential to quickly alleviate ADHD symptoms, offering an alternative for those who may not respond to or tolerate other stimulant medications.

What is the effectiveness track record for methylphenidate in treating ADHD?

Research has shown that methylphenidate, which participants in this trial may receive, helps treat ADHD symptoms. Studies have confirmed that both children and adults with ADHD experience better symptom control when taking methylphenidate. For example, one study found that certain types of methylphenidate significantly reduced ADHD symptoms, especially in the morning. Evidence also suggests that methylphenidate can improve school performance and behavior in everyday situations. This medication is already approved and widely used for managing ADHD, demonstrating its effectiveness for this condition. ^{6 7 8 9 10}

Who Is on the Research Team?

Kristin L Bigos, PhD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Methylphenidate
• Placebo

Trial Overview

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.

How Is the Trial Designed?

Group I: Methylphenidate first Experimental Treatment 2 Interventions

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

Group II: Placebo first Placebo Group 2 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

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+

Published Research Related to This Trial

In a study involving 308 patients aged 6-17 with ADHD, 65% showed significant improvement after 3 weeks of treatment with Metadate CD, indicating its effectiveness in real-world clinical practice.

The majority of patients (87%) reported satisfaction with Metadate CD, and those switching from other methylphenidate formulations found it to be as effective or better, with adverse events aligning with existing safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A postmarketing clinical experience study of Metadate CD. Dirksen, SJ., D'Imperio, JM., Birdsall, D., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 105 children and adolescents with ADHD, switching from immediate-release methylphenidate (MPH) to OROS MPH (a long-acting formulation) maintained and potentially improved ADHD symptom control over 21 days.

Approximately 75% of parents and investigators rated the OROS MPH therapy as good or excellent, indicating it was well tolerated and effective, particularly in managing symptoms during the after-school period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Remschmidt, H., Hoare, P., Ettrich, C., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexmethylphenidate--Novartis/Celgene. Focalin, D-MPH, D-methylphenidate hydrochloride, D-methylphenidate, dexmethylphenidate, dexmethylphenidate hydrochloride. [2018]

In a study of 53 pediatric ADHD patients switched from OROS-MPH to Novo-MPH ER-C, 87% experienced destabilization of their condition, indicating that the two medications are not therapeutically equivalent despite being bioequivalent.

Patients switched to Novo-MPH ER-C reported a shorter duration of effect and different side effects compared to those who remained on OROS-MPH, suggesting that treatment disruptions can significantly impact ADHD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical impact of switching attention deficit hyperactivity disorder patients from OROS(®)-MPH to Novo-MPH ER-C(®): A paediatric practice review. van Stralen, JP.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 28 children aged 6-12, lisdexamfetamine dimesylate (LDX) effectively reduced ADHD symptoms, but stimulant-naïve children experienced more severe treatment-emergent adverse events (TEAEs) like trouble sleeping and stomach pain compared to those with prior stimulant exposure.

The study suggests that previous exposure to stimulant medications may influence the type and severity of side effects experienced, highlighting the need for further research with larger samples to better understand these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in medication treatment-naïve children with attention-deficit/hyperactivity disorder: results from a small, controlled trial of lisdexamfetamine dimesylate. Wigal, SB., Wong, AA., Jun, A., et al.[2015]

In a 7-week study involving 226 adults with ADHD, OROS methylphenidate significantly improved ADHD symptoms compared to placebo, as shown by lower scores on the Adult ADHD Investigator Symptom Report Scale.

The treatment was well tolerated, with no serious adverse events reported, and a higher percentage of participants on OROS methylphenidate were classified as responders compared to those on placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. Adler, LA., Zimmerman, B., Starr, HL., et al.[2022]

A review of the French Pharmacovigilance database revealed 21 reported adverse drug reactions related to methylphenidate, with 16 cases suspected to be linked to the medication; these were mostly mild and resolved quickly.

The findings indicate that there is no evidence of methylphenidate misuse or overuse among the 1300 to 4000 children treated in France, supporting the need for continued strict prescription regulations to prevent potential misuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Utilization of methylphenidate(Ritalin) in France]. Frances, C., Hoizey, G., Millart, H., et al.[2013]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on methylphenidate controlled-delivery capsules (Equasym XL, Metadate CD) in the treatment of children and adolescents with attention-deficit hyperactivity disorder. Anderson, VR., Keating, GM.[2019]

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