Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities

• Register: ClinicalTrials.gov
• Last refreshed on: 3 June 2024
• Main ID: NCT05301361
• Date of registration: 08/03/2022
• Prospective Registration: Yes
• Primary sponsor: University of California, Davis
• Public title: Sensitivity of the NIH Toolbox to Stimulant Treatment in Intellectual Disabilities
• Scientific title: Sensitivity of the NIH Toolbox Cognition Battery to Stimulant Treatment in Intellectual Disabilities
• Date of first enrolment: February 1, 2023
• Target sample size: 68
• Recruitment status: Enrolling by invitation
• URL: https://clinicaltrials.gov/ct2/show/NCT05301361
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 6 Years
Age maximum: 24 Years
Gender: All

Health Condition(s) or Problem(s) studied

Intellectual Disability

Down Syndrome

Attention Deficit Hyperactivity Disorder

Fragile X Syndrome

Intervention(s)

Drug: Methylphenidate Oral Solution

Primary Outcome(s)

Composite score of NIHTB-CB Flanker, Dimensional Change Card Sort, List Sorting and Speeded Matching tests. [Time Frame: 11 weeks]

Secondary Outcome(s)

Conners 3 ADHD Rating Scale Hyperactivity/Impulsivity Scale [Time Frame: 11 weeks]

Conners 3 ADHD Rating Scale Inattention Scale [Time Frame: 11 weeks]

Secondary ID(s)

5R01HD076189-08

1970634

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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