TY - JOUR
T1 - A pilot study of atomoxetine in young children with attention-deficit/ hyperactivity disorder
AU - Kratochvil, Christopher J.
AU - Vaughan, Brigette S.
AU - Mayfield-Jorgensen, Michelle L.
AU - March, John S.
AU - Kollins, Scott H.
AU - Murray, Desiree W.
AU - Ravi, Hima
AU - Greenhill, Laurence L.
AU - Kotler, Lisa A.
AU - Paykina, Natalya
AU - Biggins, Patricia
AU - Stoner, Julie
PY - 2007/4
Y1 - 2007/4
N2 - Objective: The purpose of this study was to assess the effectiveness and tolerability of atomoxetine during acute treatment of attention-deficit/ hyperactivity disorder (ADHD) in 5 and 6 year olds. Method: Twenty two children (male n = 19, 86%) with ADHD were treated with atomoxetine for 8 weeks in a three-site, open-label pilot study. Dosing was flexible, with titration to a maximum of 1.8 mg/kg per day. Parent education on behavior management was provided as part of each pharmacotherapy visit. Results: Subjects demonstrated a mean decrease of 20.68 points (SD = 12.80, p < 0.001)) on the ADHD Rating Scale-IV (ADHD-IV-RS) total score, 10.18 (SD = 7.48, p < 0.001) on the inattentive subscale and 10.50 (SD = 7.04, p < 0.001) on the hyperactive/impulsive subscale. Clinical Global Impression-Severity (CGI-S) was improved in 82% of the children (95% CI, 66-98%) and Children's Global Assessment (CGAS) scores improved 18.91 points on average (SD = 12.20, p < 0.001). The mean final dose of atomoxetine was 1.25 mg/kg per day (SD = 0.35 mg/kg per day). Mood lability was the most commonly reported adverse event (n = 12, 54.5%). Eleven subjects (50%) reported decreased appetite and a mean weight loss of 1.04 kg (SD = 0.80 kg) (p < 0.001) was observed for the group. Vital sign changes were mild and not clinically significant. There were no discontinuations due to adverse events or lack of efficacy. Conclusion: Atomoxetine was generally effective for reducing core ADHD symptoms in the 5 and 6 year olds in this open-label study.
AB - Objective: The purpose of this study was to assess the effectiveness and tolerability of atomoxetine during acute treatment of attention-deficit/ hyperactivity disorder (ADHD) in 5 and 6 year olds. Method: Twenty two children (male n = 19, 86%) with ADHD were treated with atomoxetine for 8 weeks in a three-site, open-label pilot study. Dosing was flexible, with titration to a maximum of 1.8 mg/kg per day. Parent education on behavior management was provided as part of each pharmacotherapy visit. Results: Subjects demonstrated a mean decrease of 20.68 points (SD = 12.80, p < 0.001)) on the ADHD Rating Scale-IV (ADHD-IV-RS) total score, 10.18 (SD = 7.48, p < 0.001) on the inattentive subscale and 10.50 (SD = 7.04, p < 0.001) on the hyperactive/impulsive subscale. Clinical Global Impression-Severity (CGI-S) was improved in 82% of the children (95% CI, 66-98%) and Children's Global Assessment (CGAS) scores improved 18.91 points on average (SD = 12.20, p < 0.001). The mean final dose of atomoxetine was 1.25 mg/kg per day (SD = 0.35 mg/kg per day). Mood lability was the most commonly reported adverse event (n = 12, 54.5%). Eleven subjects (50%) reported decreased appetite and a mean weight loss of 1.04 kg (SD = 0.80 kg) (p < 0.001) was observed for the group. Vital sign changes were mild and not clinically significant. There were no discontinuations due to adverse events or lack of efficacy. Conclusion: Atomoxetine was generally effective for reducing core ADHD symptoms in the 5 and 6 year olds in this open-label study.
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U2 - 10.1089/cap.2006.0143
DO - 10.1089/cap.2006.0143
M3 - Article
C2 - 17489712
AN - SCOPUS:34249690022
SN - 1044-5463
VL - 17
SP - 175
EP - 185
JO - Journal of Child and Adolescent Psychopharmacology
JF - Journal of Child and Adolescent Psychopharmacology
IS - 2
ER -