Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-24 @ 12:05 PM
NCT ID:
NCT05301361
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
24 Years
Study:
NCT05301361
Study Brief:
Protocol Section:
NCT05301361