Open-Label Study of the Long Term Tolerability and Safety of Atomoxetine in Children With FASD and ADD/ADHD

Phase 3

Completed

Conditions: Fetal Alcohol Syndrome
Attention Deficit Hyperactivity Disorder (ADHD)

Interventions: Drug: Atomoxetine

Registration Number: NCT00418262

Lead Sponsor: University of Oklahoma

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 27

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Atomoxetine HCL (Strattera)	Atomoxetine	Teatment of children with fetal alcohol syndrome and ADHD with Atomoxetine HCL (Strattera)

Primary Outcome Measures

Name	Time	Method
Pittsburg Side-Effects Scale: Stomachaches	12 months or study duration	Stomachaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Motor Tics	12 months or study duration	Motor Tics Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale-Buccal, Lingual Movements	12 months or study duration	Buccal, Lingual Movements Parent rating of none (0), mild (1), moderate (2) or severe (3) for each manifestation.
Pittsburg Side-Effects Scale: Movements, Picking/Chewing Skin or Fingers	12 months or study duration	Movements, Picking/Chewing Skin or Fingers Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Worried/Anxious	12 months or study duration	Worried/Anxious Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Loss of Appetite	12 months or study duration	Loss of Appetite Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Dull/Tired/Listless	12 months or study duration	Dull/Tired/Listless Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Headaches	12 months or study duration	Headaches Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Crabby/Irritable	12 months or study duration	Crabby/Irritable Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Tearful/Sad/Depressed	12 months or study duration	Tearful/Sad/Depressed Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Socially Withdrawn	12 months or study duration	Socially Withdrawn Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Hallucinations	12 months or study duration	Hallucinations Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation
Pittsburg Side-Effects Scale: Trouble Sleeping	12 months or study duration	Trouble Sleeping Parent rating of none (0), mild (1) , moderate (2) or severe (3) for each manifestation.

Secondary Outcome Measures

Name	Time	Method
Compare Growth While on Atomoxetine With Growth Before Entry Into Study.	12 months or study duration	Height measured in centimeters at the time of each visit as part of the vital signs.
Determine if Changes in Behavior Seen With Short-term (Eight Weeks) Treatment of Children Are Maintained Over a Twelve Month Period.	12 months or study duration	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.