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. 2009 Apr;19(2):155-66.
doi: 10.1089/cap.2008.054.

Prospective, Naturalistic, Pilot Study of Open-Label Atomoxetine Treatment in Preschool Children With Attention-Deficit/Hyperactivity Disorder

Free PMC article

Prospective, Naturalistic, Pilot Study of Open-Label Atomoxetine Treatment in Preschool Children With Attention-Deficit/Hyperactivity Disorder

Jaswinder K Ghuman et al. J Child Adolesc Psychopharmacol. .
Free PMC article


Objective: The aim of this study was to report preliminary data regarding effectiveness and tolerability of atomoxetine in 3- to 5-year-old preschool children with attention-deficit/hyperactivity disorder (ADHD).

Methods: Nine boys and 3 girls (mean age = 5.0 +/- 0.72 years) diagnosed with ADHD were treated with atomoxetine in an open-label pilot study. Atomoxetine was gradually titrated to a maximum dose of 1.8 mg/kg per day.

Results: There was a significant effect of time from baseline to end point on the parent-rated hyperactivity/impulsivity Swanson Nolan and Pelham (SNAP-IV-HI) subscale ratings (F[9, 11] = 6.32, p < 0.0001). The mean difference between the baseline and end-point parent SNAP-IV-HI scores was 10.2 +/- 7.3 (p = 0.0005). The rate of positive response (defined as at least a 30% reduction in the end-point parent SNAP-IV-HI scores and a Clinical Global Impressions-Improvement [CGI-I] rating of Much Improved or Very Much Improved) was 75%. The Children's Global Assessment Scale scores improved significantly over time [F(9, 11) = 6.24 p < 0.001]. The mean end-point daily dose of atomoxetine was 1.59 +/- 0.3 mg/kg. A high proportion (66.7%) of the preschoolers experienced side effects with atomoxetine. Side effects of defiance, tantrums, aggression, and irritability were most disconcerting to parents, and gastrointestinal complaints were the most commonly reported adverse effects. One child was terminated from the study due to "chest ache." There were no changes in weight, height, or cardiovascular measures.

Conclusion: This open-label pilot study provides preliminary evidence of effectiveness and tolerability of atomoxetine for treating ADHD in preschool children, although double-blind, randomized, placebo-controlled studies are needed to confirm this.


FIG. 1.
FIG. 1.
Parent SNAP-IV Hyperactive/Impulsive Subscale Ratings at baseline and each titration and maintenance visit for the intent-to-treat sample (N = 12) Error bars depict confidence intervals. SNAP = Swanson, Nolan and Pelham scale; T = titration visit; M = dosage maintenance and observation visit; #1 = first child completed titration; #2 = median and modal number of titration visits; #3  = last child completed titration; § n = 12 at each time point, tabulated number represents the number of preschoolers whose dose is still being titrated for the T visits and number of preschoolers completing dosage maintenance and observation phase for the M visits.
FIG. 2.
FIG. 2.
(A) Safety outcome: Side Effect Rating Scale Parent Ratings (N = 12). *Highest severity rating at any titration or maintenance visit relative to the baseline rating. (B) Safety outcome: Spontaneously reported adverse events (N = 12). *Mean total duration in days and standard deviation of adverse event. **Highest severity rating at any titration or maintenance visit.

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