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Effect of atomoxetine on quality of life and family burden: results from a randomized, placebo-controlled, double-blind study in children and adolescents with ADHD and comorbid oppositional defiant or conduct disorder

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Abstract

Purpose

To evaluate the effect of atomoxetine on quality of life (QoL) and family burden in children and adolescents with attention deficit/hyperactivity disorder (ADHD) and comorbid oppositional defiant (ODD) or conduct disorder (CD).

Methods

This secondary analysis was based on a randomized, double-blind, 9-week study of atomoxetine (target dose 1.2 mg/kg body weight) versus placebo. The study included 180 patients (atomoxetine 121, placebo 59), aged 6–17 years. QoL was measured using the KINDL-R questionnaire. The total score encompasses six dimensions (or subscales) measuring QoL in terms of “physical well-being”, “emotional well-being”, “self-esteem”, “friends”, “family”, and “school”. Family burden of illness was measured using the FaBel questionnaire.

Results

With atomoxetine, the KINDL-R total score improved significantly (P = 0.021) more than with placebo. This improvement also applied to the subscales except for “physical well-being” (opposite effect) and “school” (no effect). No significant treatment group differences were seen on the FaBel questionnaire. No differences were found between the fast and slow titration groups in terms of ADHD, ODD, and disruptive behavior severity. Furthermore, no such differences were observed for QoL and family burden.

Conclusions

This study suggests positive effects of atomoxetine on quality of life, as measured by the KINDL-R scores on emotional well-being, self-esteem, friends and family, in children and adolescents with ADHD and comorbid ODD/CD. No significant treatment effects were seen on family burden, as measured by FaBel total score.

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Acknowledgments

The study was funded by Lilly Deutschland GmbH, Bad Homburg Germany.

Conflict of interest

The study was funded by Lilly Deutschland GmbH, the German affiliate of Eli Lilly and Company. Data were analyzed by PSI St. Petersburg, Russia. The protocol of this study was developed by Ralf W. Dittmann, Peter M. Wehmeier, and Alexander Schacht. The manuscript was drafted by Peter M. Wehmeier (PMW), Alexander Schacht (AS), Christian Schneider-Fresenius (CSF), Martin Lehmann (ML), and Karin Helsberg (KH). All are full-time employees of Lilly Deutschland. Ralf W. Dittmann (RWD) is a former employee of Lilly Deutschland and now holds the Eli Lilly Endowed Chair of Pediatric Psychopharmacology at the Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Mannheim, University of Heidelberg, Germany. RWD, MB, and URS reviewed the manuscript and provided substantial additional content.

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Authors and Affiliations

  1. Medical Department, Lilly Deutschland GmbH, Werner-Reimers-Str. 2–4, 61352, Bad Homburg, Germany

    Peter M. Wehmeier, Alexander Schacht, Karin Helsberg, Christian Schneider-Fresenius & Martin Lehmann

  2. Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Mannheim, University of Heidelberg, Heidelberg, Germany

    Peter M. Wehmeier

  3. Eli Lilly Endowed Chair of Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Mannheim, University of Heidelberg, Heidelberg, Germany

    Ralf W. Dittmann

  4. Department of Medical Psychology, Center of Psychosocial Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany

    Monika Bullinger

  5. Research Unit Child Public Health, Department of Psychosomatics in Children and Adolescents, University Hospital Hamburg-Eppendorf, Hamburg, Germany

    Ulrike Ravens-Sieberer

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  1. Peter M. Wehmeier
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Correspondence to Peter M. Wehmeier.

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Statistical consultant—Alexander Schacht.

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Wehmeier, P.M., Schacht, A., Dittmann, R.W. et al. Effect of atomoxetine on quality of life and family burden: results from a randomized, placebo-controlled, double-blind study in children and adolescents with ADHD and comorbid oppositional defiant or conduct disorder. Qual Life Res 20, 691–702 (2011). https://doi.org/10.1007/s11136-010-9803-5

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