Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD (NCT00417794) | Clinical Trial Compass
CompletedPhase 1
Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD
United States38 participantsStarted 2005-08
Plain-language summary
The purpose of this study is to determine if atomoxetine hydrochloride improves inattention, hyperactivity, and impulsivity problems in children exposed to alcohol during birth.
Who can participate
Age range
4 Years – 11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used the ADHD Rating Scale-IV to measure effectiveness — can you explain what that scale actually measures, and whether those results would translate to meaningful day-to-day improvements for my child?
2Since this was a Phase 1 trial, its main focus was likely on safety and dosing rather than proving atomoxetine works for kids with Fetal Alcohol Syndrome — does that mean there's still a lot we don't know about whether this drug is truly effective for FAS-related ADHD?
3Now that this trial is completed, are the results published or available anywhere, and do they change your thinking about whether atomoxetine is an appropriate option for my child compared to other ADHD treatments?
4Children with Fetal Alcohol Syndrome can have unique neurological differences — based on what this trial found, are there specific safety concerns about using atomoxetine in kids with FAS that I should be aware of before considering it?
5Would it make more sense to try a more established or standard ADHD treatment first, given that this was only a Phase 1 study and the evidence for atomoxetine specifically in children with FAS may still be limited?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.