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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00381758
Eligibility Criteria:
Inclusion Criteria:
* 6 -12 years of age, inclusive
* Have a diagnosis of ADHD
* Receiving an approved form of MPH (methylphenidate) and have demonstrated clinical improvement during this treatment.
Exclusion Criteria:
* IQ below 80.
* The patient, or a first-degree relative, has a confirmed diagnosis of Tourette's syndrome or a clinically significant tic disorder.
* History of seizures (excluding uncomplicated childhood febrile seizures).
* Myocardial infarction within 3 months of study entry, or has a history of cardiac disease, congenital cardiac abnormality, glaucoma, hyperthyroidism.
* Comorbid psychiatric diagnosis.
* Exhibits extreme aggressive behavior or destruction of property, marked anxiety, tension, or agitation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT00381758
Study Brief:
Protocol Section:
NCT00381758