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.
OBJECTIVE
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.
Medical Department, Lilly Deutschland GmbH, Werner-Reimers-Strasse 2-4, Bad Homburg, Germany. wehmeier_peter@lilly.com
Peter M
PM
Wehmeier
Alexander
A
Schacht
Ralf W
RW
Dittmann
Karin
K
Helsberg
Christian
C
Schneider-Fresenius
Martin
M
Lehmann
Monika
M
Bullinger
Ulrike
U
Ravens-Sieberer
D000223:Adaptation, Psychological; D000293:Adolescent; D000294:Adolescent Behavior; D018759:Adrenergic Uptake Inhibitors / Q000494:pharmacology / Q000627:therapeutic use*; D000704:Analysis of Variance; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D002648:Child; D002669:Child Welfare; D019955:Conduct Disorder / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D016001:Confidence Intervals; D004311:Double-Blind Method; D005195:Family Relations; D005260:Female; D006801:Humans; D008297:Male; D011437:Propylamines / Q000494:pharmacology / Q000627:therapeutic use*; D011594:Psychometrics; D012649:Self Concept; D013315:Stress, Psychological; D013337:Students, Medical; D011795:Surveys and Questionnaires
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride