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Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

A Study of the Efficacy of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal Alcohol Syndrome or Effects

NCT00417794•University of Oklahoma

View on ClinicalTrials.gov

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.

Detailed Description

Abnormalities of attention, function, and activity level in children exposed to alcohol in utero share similarities and differences to children who do not have alcohol exposure. Previous psychological studies have examined either core attention deficit hyperactivity disorder (ADHD)symptoms of hyperactivity, inattention, and impulsivity or hypothesized neuropsychological differences in children with fetal alcohol syndrome (FAS) and ADHD. Atomoxetine Hydrochloride is a non-stimulant medication used to treat ADHD. This study will determine if atomoxetine HCL significantly reduces symptoms of ADD/ADHD in children with fetal alcohol exposure.

Eligibility

Age

4 - 11 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

OU Child Study Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

August 1, 2005

Primary Completion Date

April 22, 2015

Completion Date

April 22, 2015

Last Updated

April 10, 2017

Enrollment

ACTUAL participants

Conditions

Fetal Alcohol SyndromeAttention Deficit Disorder With Hyperactivity (ADHD)Attention Deficit Disorder (ADD)

Interventions

Strattera

DRUG

Placebo

DRUG

RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

NCT04395196

Fetal Alcohol Spectrum DisordersFetal Alcohol Syndrome

View study

COMPLETED

The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder

NCT07041333

Attention Deficit Disorder With Hyperactivity (ADHD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD

Inclusion Criteria

Exclusion Criteria

RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure

The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder

Assessment of Handwriting Skills in a Sample of Egyptian Children with Attention-Deficit Hyperactivity Disorder

Multisensorial Analysis of Human Activity for Diagnosis and Early Detection of Functional Limitations

Neurocognitive Habilitation for Children With Fetal Alcohol Syndrome (FAS)/Alcohol-Related Neurodevelopmental Disorder (ARND)

Fetal Alcohol Syndrome: Socio-Cognitive Habilitation