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:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT04639960
Eligibility Criteria:
Inclusion Criteria:
* Male or female with confirmed 22q11DS diagnosis.
* Minimum age of 8 years or maximum age of 25 years and 11 months.
* Sufficient verbal expression and comprehension skills to understand and follow instructions based on initial interview.
Exclusion Criteria:
* Participants younger than 8 years and older that 25 years and 11 months.
* Previous adverse experience with risperidone
* Psychotic symptoms requiring sustained antipsychotic treatment
* Corrected QT (QTc) distance at baseline electrocardiogram above 460 milliseconds or elongation at control electrocardiogram (Day 6 of treatment) superior to 30 milliseconds with functional complaint.
* Pregnancy or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
25 Years
Study:
NCT04639960
Study Brief:
Protocol Section:
NCT04639960