Clinical trial NCT00418262: Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD
Official title: An Open-label Study of the Long Term Tolerability and Safety of Atomoxetine in Treating the Inattention, Impulsivity and Hyperactivity in Children With Fetal-Alcohol Syndrome or Effects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fetal Alcohol Syndrome
Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: fetal alcohol syndrome
attention deficit disorder
attention deficit disorder with hyperactivity
ADD
FAS
FASD
ADHD
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Mark L. Wolraich
First posted: 2007-01-04
Enrollment: 27
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label
Primary purpose: TREATMENT

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

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 (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 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.

Primary outcomes:
measure: Pittsburg Side-Effects Scale: Motor Tics
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale-Buccal, Lingual Movements
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Worried/Anxious
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Dull/Tired/Listless
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Headaches
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Stomachaches
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Crabby/Irritable
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Socially Withdrawn
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Hallucinations
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Loss of Appetite
timeFrame: 12 months or study duration
measure: Pittsburg Side-Effects Scale: Trouble Sleeping
timeFrame: 12 months or study duration
Secondary outcomes:
measure: Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
timeFrame: 12 months or study duration
measure: Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
timeFrame: 12 months or study duration
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OU Child Study Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Laura J McGuinn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: