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 @ 11:00 PM
Ignite Modification Date:
2025-12-24 @ 11:00 PM
NCT ID:
NCT01886469
Eligibility Criteria:
Main Inclusion Criteria
* Male and female adolescents (12-17 years; Stage 1) and children (6-11 years; Stage 2).
* Diagnosis of ADHD and confirmed on Kiddie-Schedule for Affective Disorders and Schizophrenia (K-SADS).
* ADHD symptoms controlled on a stable dose of Vyvanse, Adderall XR and or Dexedrine.
* Provision of informed consent (from parent\[s\] or legal representative\[s\]) and assent (from subject) for patients.
Main Exclusion Criteria
* Comorbid psychiatric diagnosis (e.g., psychosis, bipolar disorder).
* History of seizures or current diagnosis or family history of Tourette's disorder.
* Use of prescription drugs (except Vyvanse, Dexedrine or Adderall XR) the 14 days and over-the-counter drugs (except birth control) the 30 days before the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT01886469
Study Brief:
Protocol Section:
NCT01886469