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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00485550
Eligibility Criteria:
Inclusion Criteria:
* Patients will be at least 6 years of age and not more than 12 years of age at visit 1
* Patients must meet DSM-IV diagnostic criteria for ADHD
* Patients must be retrospectively identified as stimulant non-responders
* Patients must be of normal intelligence as assessed by the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgment, to achieve a score of greater than or equal to 70 on an IQ test)
* Patients must be able to swallow capsules
Exclusion Criteria:
* Patients who weigh less than 22 kg or more than 60 kg at study entry
* Patients who have a history of Bipolar I or Bipolar II Disorder, psychosis, or pervasive developmental disorder
* Patients who meet DSM-IV criteria for anxiety disorder or autism
* Patients with a history of any seizure disorder and/or Rolandic seizures (other than febrile seizures) or prior electroencephalogram (ECG) abnormalities in the absence of seizures, or patients who have taken (or are currently taking) anticonvulsants for seizure control
* Patients with a history of severe allergies to more than one class of medication or multiple adverse drug reactions, including hypersensitivity to MPH
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT00485550
Study Brief:
Protocol Section:
NCT00485550