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Methylphenidate for ADHD

Phase 4
Waitlist Available
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 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up 8 hours
Awards & highlights

Study Summary

This trial will study how well a medication works in treating ADHD patients, and will also look at how different genetic variants may affect the medication's efficacy.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum methylphenidate plasma concentration (Cmax)
Secondary outcome measures
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%
Worried/Anxious
21%
Dull, tired, listless
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
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

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,241 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,547 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
523,786 Total Patients Enrolled
8 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
674 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University of FloridaOTHER
1,340 Previous Clinical Trials
715,196 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
30 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Methylphenidate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03781752 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Methylphenidate
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT03781752 — Phase 4
Methylphenidate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03781752 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT03781752 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other research projects explored the use of Methylphenidate?

"Methylphenidate initially received scientific attention in 2002 at PRODAH and the Hospital de Clínicas de Porto Alegre. To date, 206 studies have been completed on this medication with 29 more trials still actively recruiting participants. Many of these are located within New york City."

Answered by AI

How many human participants are involved in this experiment?

"This trial necessitates the inclusion of 500 participants that meet certain criteria. Participants can register to partake in this clinical study at multiple sites, such as Icahn School of Medicine at Mount Sinai (New york) and University of Florida (Gainesville)."

Answered by AI

Could I be a participant in this ongoing research?

"This study seeks to enrol 500 children and young adults between the ages of 6 and 26 with a primary diagnosis of ADHD. Other criteria for inclusion involve having previously participated in MPH trials, allowing them to be invited back for more extensive pharmacokinetic testing."

Answered by AI

Are there any open slots available for participation in this investigation?

"Affirmative. Information published on clinicaltrials.gov indicates that this medical experiment is currently recruiting patients. It has been available since March 4th 2018 and was most recently updated on April 5th 2022, with the goal of achieving 500 participants across four sites."

Answered by AI

Does this experiment seek to enroll participants above the age of 35?

"According to the study's eligibility prerequisites, participants must be between 6 and 26 years old."

Answered by AI

Has the FDA sanctioned Methylphenidate for therapeutic use?

"The safety of Methylphenidate is rated highly due to its Phase 4 status, giving it a score of 3. This implies that the medication has been approved for use in clinical settings."

Answered by AI

Are there any establishments in North America that are currently administering this research?

"Patients who are interested in this clinical trial can receive treatment at Icahn School of Medicine at Mount Sinai (New york, New York), University of Florida (Gainesville, Florida), Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio) and 4 additional medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
Washington
New York
Other
How old are they?
< 18
18 - 65
What site did they apply to?
University of Florida
Other
Seattle Children's Hospital
Icahn School of Medicine at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
2

Why did patients apply to this trial?

I really need something that Can help my ADHD better than what I’m already taking.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD
Jeffrey Newcorn 2018. "Carboxylesterase 1 Genetic Variation and Methylphenidate in ADHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03781752.
All > Adhd
~26 spots leftby Sep 2024
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