Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study

Sep 1, 2009European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Atomoxetine treatment for children and teens with ADHD and oppositional defiant disorder compared to placebo in Italy

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Abstract

Only 2 of the 156 patients improved after the parent training program.

Atomoxetine treatment resulted in a mean decrease of -8.1 in ADHD symptoms compared to -2.0 in the placebo group, showing significant improvement (p<0.001).
The ODD symptoms improved by a mean of -2.7 in the atomoxetine group versus -0.3 in the placebo group, indicating significant differences (p=0.001).
A median change of -1.0 in the CGI-ADHD-S score was observed in the atomoxetine group, while no change was noted in the placebo group (p<0.001).
Significant improvements were found in the risk avoidance domain and emotional comfort in the CHIP-CE scores for the atomoxetine group.
All Conners Parents (CPRS-R:S) and Teacher (CTRS-R:S) subscales showed improvement with atomoxetine, except for cognitive problems in the CTRS-R:S.
Atomoxetine was well tolerated, with only 3 patients discontinuing due to adverse events and no significant changes in body weight, height, or vital signs.

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OBJECTIVE: The primary aim of this study was to assess the efficacy of atomoxetine in improving ADHD and ODD symptoms in paediatric patients with ADHD and comorbid oppositional defiant disorder (ODD), non-responders to previous psychological intervention with parent support.

METHODS: This was a multicentre, randomised, placebo-controlled trial conducted in patients aged 6-15 years, with ADHD and ODD diagnosed according to the DSM-IV criteria by a structured clinical interview (K-SADS-PL). Only subjects who are non-responders to a 6-week standardized parent training were randomised to atomoxetine (up to 1.2 mg/kg/day) or placebo (in a 3:1 ratio) for the following 8-week double blind phase.

RESULTS: Only 2 of the 156 patients enrolled for the parent support phase (92.9% of males; mean age: 9.9 years), improved after the parent training program; 139 patients were randomised for entering in the study and 137 were eligible for efficacy analysis. At the end of the randomised double blind phase, the mean changes in the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV) ADHD subscale were -8.1+/-9.2 and -2.0+/-4.7, respectively in the atomoxetine and in the placebo group (p<0.001 between groups); changes in the ODD subscale were -2.7+/-4.1 and -0.3+/-2.6, respectively in the two groups (p=0.001 between groups). The CGI-ADHD-S score decreased in the atomoxetine group (median change at endpoint: -1.0) compared to no changes in the placebo group (p<0.001 between groups). Statistically significant differences between groups, in favour of atomoxetine, were found in the CHIP-CE scores for risk avoidance domain, emotional comfort and individual risk avoidance subdomains. An improvement in all the subscales of Conners Parents (CPRS-R:S) and Teacher (CTRS-R:S) subscales was observed with atomoxetine, except in the cognitive problems subscale in the CTRS-R:S. Only 3 patients treated with atomoxetine discontinued the study due to adverse events. No clinically significant changes of body weight, height and vital signs were observed in both groups.

CONCLUSIONS: Treatment with atomoxetine of children and adolescents with ADHD and ODD, who did not initially respond to parental support, was associated with improvements in symptoms of ADHD and ODD, and general health status. Atomoxetine was well tolerated.

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Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study

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