Determine if atomoxetine is safe and well tolerated by children with fetal alcohol syndrome.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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.
OU Child Study Center
Oklahoma City, Oklahoma, United States
Pittsburg Side-Effects Scale: Motor Tics
Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale-Buccal, Lingual Movements
Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers
Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Worried/Anxious
Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Dull/Tired/Listless
Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Headaches
Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Stomachaches
Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
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Pittsburg Side-Effects Scale: Crabby/Irritable
Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed
Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Socially Withdrawn
Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Hallucinations
Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Loss of Appetite
Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Time frame: 12 months or study duration
Pittsburg Side-Effects Scale: Trouble Sleeping
Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.
Time frame: 12 months or study duration
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.
Parent rate the frequency of 18 of their child's behaviors from not at all (0), just a little (1) , pretty much (2) to very much (3) for each behavior. The Item scores were summed to arrive at a total score which ranged from 0 to 54. The higher the score, the worse the behavior.
Time frame: 12 months or study duration
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.
Height measured in centimeters at the time of each visit as part of the vital signs.
Time frame: 12 months or study duration