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Central Nervous System Stimulant

Methylphenidate for Intellectual Disability and ADHD

Phase 1
Waitlist Available
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Mental age 4.0 or higher (Stanford Binet)
Ability to complete valid NIHTB-CB tests at screening/baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights

Study Summary

This trialstudies the effects of medication on cognition in kids & teens with intellectual disability and ADHD. 68 participants will receive drug or placebo in a 1:1 ratio, monitored and assessed for 5 weeks.

Who is the study for?
This trial is for children and adolescents aged 6-17 with intellectual disabilities (ID) like Down Syndrome or Fragile X, who also have ADHD. They must have an IQ above 50 but below 80, a mental age of at least 4 years, and be able to complete certain cognitive tests. Those recently on stimulants or with conditions like uncontrolled epilepsy or severe psychiatric disorders cannot participate.Check my eligibility
What is being tested?
The study tests if extended-release liquid methylphenidate (a medication commonly used for ADHD) affects cognition in participants with ID and ADHD. It's a double-blind trial where half the kids get the drug and half get a placebo without knowing which one they're taking. The dose starts low and can increase unless side effects appear.See study design
What are the potential side effects?
Possible side effects include reactions similar to other stimulant medications: trouble sleeping, decreased appetite, headaches, increased heart rate and blood pressure. If any serious side effects occur, the medication dose will be lowered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My mental age is 4 years or older according to the Stanford Binet test.
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I can complete the required cognitive tests.
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My IQ is between 50 and 80.
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I have been diagnosed with ADHD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests.
Secondary outcome measures
Conners 3 ADHD Rating Scale Hyperactivity/Impulsivity Scale
Conners 3 ADHD Rating Scale Inattention Scale

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MethylphenidateActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

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
2,674,673 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
5,979 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
University of California, DavisLead Sponsor
910 Previous Clinical Trials
4,706,923 Total Patients Enrolled
7 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
336 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Methylphenidate Oral Solution (Central Nervous System Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT05301361 — Phase 1
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Methylphenidate, Placebo
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Methylphenidate Oral Solution Highlights & Side Effects. Trial Name: NCT05301361 — Phase 1
Methylphenidate Oral Solution (Central Nervous System Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301361 — Phase 1

Frequently Asked Questions

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

How many participants are eligible for this clinical trial?

"Yes, the research hosted on clinicaltrials.gov reveals that this medical experiment is currently searching for participants. This investigation was first posted in February of 2023 and has been recently updated as October 24th 2022. There are 68 slots available across 3 different sites."

Answered by AI

Are recruitment efforts for this experiment still ongoing?

"The details on clinicaltrials.gov indicate that this trial is still open for enrolment, with the initial posting occurring February 1st 2023 and the most recent update issued October 24th 2022."

Answered by AI

What potential risks accompany taking Methylphenidate?

"The safety of Methylphenidate is judged to be a 1 due to its Phase 1 status, indicating that there have been few studies conducted on the medication's efficacy and safety."

Answered by AI

Is there an age restriction to qualify for this clinical investigation?

"This trial is seeking participants who are within the juvenile age range, being over 6 and under 17 years of age."

Answered by AI

Who has the capacity to be included in this experiment?

"This medical trial is currently enrolling 68 minors (age 6-17) with intellectual disability and ADHD. All participants must be capable of valid NIHTB-CB tests, have an IQ between 50-80, a mental age score of 4 or above on the Stanford Binet test, and provide diagnosis for both conditions."

Answered by AI

Who else is applying?

What site did they apply to?
Cincinnati Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I would like to see if there is anything better that’s works for me .
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities
David Hessl, PhD 2023. "Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05301361.
All > Fragile X Syndrome > Down Syndrome
~37 spots leftby Sep 2025
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