Abstract
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 1.8mg/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±0.3mg/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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 155-166 |
| Number of pages | 12 |
| Journal | Journal of Child and Adolescent Psychopharmacology |
| Volume | 19 |
| Issue number | 2 |
| DOIs | |
| State | Published - Apr 1 2009 |
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ASJC Scopus subject areas
- Pharmacology (medical)
- Pediatrics, Perinatology, and Child Health
- Psychiatry and Mental health
Cite this
Prospective, naturalistic, pilot study of open-label atomoxetine treatment in preschool children with attention-deficit/hyperactivity disorder. / Ghuman, Jaswinder K.; Aman, Michael G.; Ghuman, Harinder S.; Reichenbacher, Thomas; Gelenberg, Alan; Wright, Ron; Rice, Sydney A; Fort, Carolyn.
In: Journal of Child and Adolescent Psychopharmacology, Vol. 19, No. 2, 01.04.2009, p. 155-166.Research output: Contribution to journal › Article
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TY - JOUR
T1 - Prospective, naturalistic, pilot study of open-label atomoxetine treatment in preschool children with attention-deficit/hyperactivity disorder
AU - Ghuman, Jaswinder K.
AU - Aman, Michael G.
AU - Ghuman, Harinder S.
AU - Reichenbacher, Thomas
AU - Gelenberg, Alan
AU - Wright, Ron
AU - Rice, Sydney A
AU - Fort, Carolyn
PY - 2009/4/1
Y1 - 2009/4/1
N2 - 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 1.8mg/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±0.3mg/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.
AB - 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 1.8mg/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±0.3mg/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.
UR - http://www.scopus.com/inward/record.url?scp=65249142203&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65249142203&partnerID=8YFLogxK
U2 - 10.1089/cap.2008.054
DO - 10.1089/cap.2008.054
M3 - Article
C2 - 19364293
AN - SCOPUS:65249142203
VL - 19
SP - 155
EP - 166
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
SN - 1044-5463
IS - 2
ER -