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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00417794
Eligibility Criteria:
Inclusion Criteria:
* Patient must be between the ages of 4 and 11 years at the time of entry into the study.
* Patients must meet diagnostic criteria for FASD
* Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of \> or = to 90%ile for age and gender for either subtest or total score if greater than 5 years of age.
* Patients who enter the study at visit 1 taking stimulant medication must be medication-free for at least 24 hours before visit 2.
* History and physical exam must reveal no clinically significant abnormalities that would preclude safe participation in the study.
* Patients must be able to swallow capsules.
* Patients must be of a sufficient developmental level (\~3 yrs) to participate in the study.
* Patients and parents must be able to communicate effectively with the investigator and coordinator and be judged reliable to keep appointments and participate in data collection.
* Teacher must agree to cooperate with the study. Children less than 6 years old must have completed a course of PCIT and still meet DSM-IV criteria for ADHD.
Exclusion Criteria:
* Have received an in investigational medication in the past 30 days.
* Are currently on a medication treatment that is effective (ADHDRS-IV score within 1 SD of average) and well tolerated.
* Have significant current medical conditions that could be exacerbated or compromised by atomoxetine.
* Have used MAOIs within one month prior to visit 2.
* Patients with hypertension.
* Patients with a previous diagnosis of bipolar disorder, psychosis, or autism spectrum disorder.
* Patients taking anticonvulsants for seizure control.
* Patients taking another psychotropic medication or health food supplements purported to have central nervous system activity within 5 half-lives of visit 2.
* Patients with Tourette Disorder or any other neurological condition that would interfere with their ability to receive treatment or comply with monitoring.
* Pubertal girls.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT00417794
Study Brief:
Protocol Section:
NCT00417794