What side effects are associated with this type of intervention?

Methylphenidate, a common treatment for ADHD, is generally well-tolerated but can have side effects. These may include appetite reduction, sleep-onset difficulties, irritability, and emotional outbursts. Other potential side effects are increased heart rate, elevated blood pressure, and gastrointestinal issues. It is important to monitor these side effects and adjust treatment as necessary under medical supervision.

What prior FDA approvals exist?

Methylphenidate, a commonly used stimulant for ADHD, has been approved by the FDA in various formulations, including immediate-release and extended-release versions, to improve efficacy and reduce dosing frequency. Other related stimulant medications approved for ADHD treatment include amphetamines, such as mixed amphetamine salts and lisdexamfetamine. These medications have shown significant short-term improvements in ADHD symptoms and are generally well-tolerated, although they may have different side effect profiles. The FDA has also approved non-stimulant medications like atomoxetine and extended-release guanfacine, which offer alternative treatment options for patients who may not tolerate stimulants well.

What other types of research exist?

Promising novel alternatives to methylphenidate for ADHD treatment include: 1) Atomoxetine, a selective norepinephrine reuptake inhibitor, which has shown efficacy in improving attention and reducing hyperactivity. 2) Guanfacine and Clonidine, alpha-2 adrenergic agonists, which can help with impulsivity and hyperactivity. 3) Viloxazine, a norepinephrine reuptake inhibitor recently approved for ADHD, which has shown positive effects on attention and behavior. These alternatives offer different mechanisms of action and may be suitable for patients who do not respond well to methylphenidate.

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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

Must not have

past or current neurological disorder

head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 90 minutes after dose

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of neurological disorders.

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I have had a head injury with unconsciousness or lasting problems in the past year.

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I have a health condition that is not well-managed.

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My cognitive issues are not due to ADHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 90 minutes after dose

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

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

Primary study objectives

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%

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Methylphenidate

2014

Completed Phase 4

~431850

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility 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

Methylphenidate and amphetamines are the most common treatments for ADHD. These medications primarily work by increasing the levels of dopamine and norepinephrine in the brain. Methylphenidate blocks the reuptake of these neurotransmitters, while amphetamines increase their release and also inhibit their reuptake. This elevation in neurotransmitter levels enhances attention and focus while reducing hyperactive and impulsive behaviors. Understanding these mechanisms is crucial for ADHD patients because it explains how these medications help manage core symptoms, thereby improving daily functioning and quality of life.

Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis.Comparing the efficacy of medications for ADHD using meta-analysis.A controlled trial of methylphenidate in adults with attention deficit/hyperactivity disorder and substance use disorders.