Status:
ENROLLING_BY_INVITATION
Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Intellectual Disability
Fragile X Syndrome
Eligibility:
All Genders
6-24 years
Phase:
PHASE1
Brief Summary
This study is a randomized, double-blind, placebo-controlled, crossover trial of extended-release liquid methylphenidate (XRMPH) to evaluate the sensitivity of the NIH Toolbox Cognition Battery (NIHTB...
Eligibility Criteria
Inclusion
- IQ below 80
- Mental age 3.0 or higher (Stanford Binet)
- Diagnosis of Intellectual Disability
- Diagnosis of ADHD
- Ability to complete valid NIHTB-CB tests at screening/baseline
Exclusion
- stimulant use within 2 weeks prior to randomization
- history of a sensitivity reaction to stimulants
- presence of significant comorbid psychiatric or medical disorder/illness deemed by the site physician as inappropriate for stimulant use (uncontrolled epilepsy, bipolar disorder, psychosis, severe OCD, hypertension, tachycardia hypertension, failure to thrive, psychosis for example)
- a household resident with a current substance abuse disorder
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2026
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT05301361
Start Date
February 1 2023
End Date
September 29 2026
Last Update
December 15 2025
Active Locations (3)
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1
UC Davis MIND Institute
Sacramento, California, United States, 95817
2
Rush University
Chicago, Illinois, United States, 60612
3
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229