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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
All Individual Drugs Already Approved

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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
2,068 Previous Clinical Trials
2,747,386 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
946 Previous Clinical Trials
4,756,062 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
~20 spots leftby Sep 2025
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