Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Condition: Fetal Alcohol Syndrome; Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Fetal Alcohol Spectrum Disorders; Syndrome; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine
Intervention description: Titrating with oral administration of 0.25 mg/kg, 0.50 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with food.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: open label
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: fetal alcohol syndrome; attention deficit disorder; attention deficit disorder with hyperactivity; ADD; FAS; FASD; ADHD

Summary:

      Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must have been between the ages of 4 and 11 years at the time of entry into
             the double blind study.

          -  Patients must meet diagnostic criteria for FASD.

          -  Patient must, at entry into doubleblind study, have met DSM-IV criteria for ADHD, any
             subtype. And must have an ADHDRS-IV score of > or + 90% for age and gender on either
             subtest or total score for children above 5 years of age.

          -  Patients will continue atomoxetine/placebo until entry nto this study.

          -  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 mental age (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.

        Exclusion Criteria:

          -  Have received an investigational medication other than atomoxetine in the previous 30
             days.

          -  Have significant current medical conditions that could be exacerbated or compromised
             by atomoxetine.

          -  Have used MAOIs within one month prior to visit 1.

          -  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 1.

          -  Patients with Tourette Disorder or any other neurological condition that would
             interfere with their ability to receive treatment or comply with monitoring.

          -  Pubertal girls.