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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.
Eur Neuropsychopharmacol. 2009 Nov; 19(11):822-34.EN

Abstract

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.

Authors+Show Affiliations

Medical Department, Eli Lilly Italia, Italy.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19716683

Citation

Dell'Agnello, Grazia, et al. "Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-deficit/hyperactivity Disorder and Comorbid Oppositional Defiant Disorder: a Placebo-controlled Italian Study." European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, vol. 19, no. 11, 2009, pp. 822-34.
Dell'Agnello G, Maschietto D, Bravaccio C, et al. Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study. Eur Neuropsychopharmacol. 2009;19(11):822-34.
Dell'Agnello, G., Maschietto, D., Bravaccio, C., Calamoneri, F., Masi, G., Curatolo, P., Besana, D., Mancini, F., Rossi, A., Poole, L., Escobar, R., & Zuddas, A. (2009). Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study. European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology, 19(11), 822-34. https://doi.org/10.1016/j.euroneuro.2009.07.008
Dell'Agnello G, et al. Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-deficit/hyperactivity Disorder and Comorbid Oppositional Defiant Disorder: a Placebo-controlled Italian Study. Eur Neuropsychopharmacol. 2009;19(11):822-34. PubMed PMID: 19716683.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Atomoxetine hydrochloride in the treatment of children and adolescents with attention-deficit/hyperactivity disorder and comorbid oppositional defiant disorder: A placebo-controlled Italian study. AU - Dell'Agnello,Grazia, AU - Maschietto,Dino, AU - Bravaccio,Carmela, AU - Calamoneri,Filippo, AU - Masi,Gabriele, AU - Curatolo,Paolo, AU - Besana,Dante, AU - Mancini,Francesca, AU - Rossi,Andrea, AU - Poole,Lynne, AU - Escobar,Rodrigo, AU - Zuddas,Alessandro, AU - ,, Y1 - 2009/08/28/ PY - 2009/01/03/received PY - 2009/07/02/revised PY - 2009/07/23/accepted PY - 2009/9/1/entrez PY - 2009/9/1/pubmed PY - 2009/12/16/medline SP - 822 EP - 34 JF - European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology JO - Eur Neuropsychopharmacol VL - 19 IS - 11 N2 - 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. SN - 1873-7862 UR - https://www.unboundmedicine.com/medline/citation/19716683/Atomoxetine_hydrochloride_in_the_treatment_of_children_and_adolescents_with_attention_deficit/hyperactivity_disorder_and_comorbid_oppositional_defiant_disorder:_A_placebo_controlled_Italian_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0924-977X(09)00193-X DB - PRIME DP - Unbound Medicine ER -