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 @ 6:29 PM
Ignite Modification Date:
2025-12-24 @ 6:29 PM
NCT ID:
NCT06673368
Eligibility Criteria:
1. Male or female, 13-17 years of age at screening.
2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes.
3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline.
4. Has side effects identified using SDSE-RS at Screening and Baseline.
5. CGI-S ≥ X (blinded) at Screening and Baseline.
6. Must be fluent in English and communicate effectively with others.
7. Both subject and parent/guardian willing and able to give informed assent/consent.
8. Parent/guardian willing to serve as informant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT06673368
Study Brief:
Protocol Section:
NCT06673368