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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT00485459
Eligibility Criteria:
Inclusion Criteria:
* Subject must have ADHD that meet DSM-IV disease diagnostic criteria as well as severity criteria
* Subjects must be aged 6 to 16 years
* Subjects must not have taken any medication used to treat ADHD or they must have completed the washout procedures
* Subjects must be able to swallow capsules
* Subjects must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 80 or more if formal IQ testing were administered.
Exclusion Criteria:
* Weigh less than 20 kg or more than 60 kg at study entry
* Have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder
* Meet DSM-IV criteria for an anxiety disorder as assessed by the investigator
* Have a history of any seizure disorder (other than febrile seizures) or prior ECG abnormalities related to epilepsy, or subjects who have taken (or are currently taking) anticonvulsants for seizure control
* Subjects who have a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT00485459
Study Brief:
Protocol Section:
NCT00485459