What side effects are associated with this type of intervention?

Common treatments for ADHD, such as d,l-Methylphenidate, often have side effects including loss of appetite, nausea, palpitations, nervousness, and irritability. Other stimulant medications like amphetamines may also cause similar side effects and can be less tolerable than methylphenidate. Long-term use requires monitoring for potential impacts on height, weight, blood pressure, and pulse. Adherence to medication regimens can be challenging, particularly for adolescents and young adults.

What prior FDA approvals exist?

The FDA has approved several formulations of methylphenidate for the treatment of ADHD, including immediate-release (e.g., Ritalin), extended-release (e.g., Concerta, Metadate CD), and novel formulations (e.g., Aptensio XR). These medications are designed to improve the core symptoms of ADHD by enhancing attention and reducing hyperactivity and impulsivity. Methylphenidate is generally well-tolerated, though it can cause side effects such as insomnia and increased blood pressure. The efficacy and safety of these drugs have been supported by numerous studies, making them a cornerstone in ADHD management.

What other types of research exist?

Promising novel alternatives to d,l-Methylphenidate for ADHD treatment in 2024 include atomoxetine, which is a non-stimulant and not metabolized by CES1, and extended-release formulations of amphetamines such as lisdexamfetamine. Additionally, new extended-release liquid formulations like NWP06 have shown efficacy in recent studies and may offer improved symptom control and patient adherence.

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Methylphenidate for ADHD

Phase 4

Recruiting

Led By Jeffrey Newcorn, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Youth ages 6-26 years with ADHD as a primary diagnosis

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up 8 hours

Awards & highlights

Summary

This trial is investigating how genetic differences in an enzyme called CES1 affect the way ADHD patients respond to the medication methylphenidate. The goal is to understand why some patients do not respond well or experience severe side effects. Methylphenidate (MPH) is a well-established treatment for ADHD, but not all patients respond to it, and some experience adverse reactions.

Who is the study for?

This trial is for young people aged 6-26 with a primary diagnosis of ADHD. It's open to those who have previously been part of MPH trials and are invited back for further study. Smokers, pregnant individuals, or those not considered healthy enough for MPH treatment by their doctors cannot participate.

What is being tested?

The trial is examining how genetic differences in an enzyme called CES1 affect the body's response to Methylphenidate (MPH), a common medication used to treat ADHD. The goal is to understand the link between CES1 gene variants and MPH effectiveness.

What are the potential side effects?

While specific side effects aren't listed here, Methylphenidate commonly includes appetite loss, stomach pain, increased heart rate, mood changes, and trouble sleeping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 26 years old and have been diagnosed with ADHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up 8 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up 8 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up 8 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum methylphenidate plasma concentration (Cmax)

Secondary study objectives

Area under the plasma concentration curve (AUCinf)

Area under the plasma concentration curve (AUClast)

Time to maximum concentration (Tmax)

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Dull, tired, listless

21%

Worried/Anxious

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1-Medication First

Phase 1 - Placebo First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

Trial Design

1Treatment groups

Experimental Treatment

Group I: MethylphenidateExperimental Treatment1 Intervention

Youth with ADHD

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD are stimulant medications, such as methylphenidate and amphetamines. These drugs primarily work by increasing the levels of neurotransmitters dopamine and norepinephrine in the brain. Methylphenidate, for example, inhibits the reuptake of these neurotransmitters, thereby enhancing their availability in the synaptic cleft. This action helps improve attention, focus, and impulse control in ADHD patients. Understanding the pharmacokinetics (PK) and pharmacodynamics (PD) of these medications, including genetic factors like CES1 variants that affect methylphenidate metabolism, is crucial for optimizing treatment efficacy and minimizing side effects. This personalized approach can lead to better management of ADHD symptoms and overall patient outcomes.

ADHD & Pharmacotherapy: Past, Present and Future: A Review of the Changing Landscape of Drug Therapy for Attention Deficit Hyperactivity Disorder.