Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities

PHASE1Enrolling by invitationINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

February 1, 2023

Primary Completion Date

September 29, 2025

Study Completion Date

September 29, 2026

Conditions
Intellectual DisabilityFragile X SyndromeDown SyndromeAttention Deficit Hyperactivity Disorder
Interventions
DRUG

Methylphenidate Oral Solution

The XRMPH or matching placebo will be started at a dose of 0.3 mg/kg/day and individually titrated over two weeks. Phone calls at the end of weeks 1, 2, and 3 will be used to collect adverse event and response data. If there is no evidence of side effects and ongoing symptoms of ADHD, the dose will be increased to 0.5 mg/kg/day at one week and 0.7 mg/kg/day at 2 weeks (maximum dose of 60 mg per day consistent with FDA labeled use in youth).

Trial Locations (3)

45229

Cincinnati Children's Hospital, Cincinnati

60612

Rush University, Chicago

95817

UC Davis MIND Institute, Sacramento

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

University of California, Davis

OTHER