Evaluation of patients' and parents' quality of life in a randomized placebo-controlled atomoxetine study in attention-deficit/hyperactivity disorder.
OBJECTIVE
The aim of this study was to demonstrate the superior efficacy of atomoxetine with respect to placebo and to compare parent and child perceptions of health-related quality of life (HRQoL).


METHODS
This randomized, placebo-controlled, 12-week parallel clinical trial included 151 untreated children/adolescents with newly diagnosed attention-deficit/hyperactivity disorder (ADHD). Parents' and patients' reports of HRQoL were obtained separately using the Child Health and Illness Profile and compared using analysis of covariance.


RESULTS
The ADHD Rating Scale baseline mean score was 39.21. Baseline HRQoL was perceived as considerably compromised by parents, especially in the risk avoidance and achievement domains (mean t-scores, 32.47 and 33.16, respectively), but less by children, and restricted to the achievement domain (mean t-score, 41.54). Atomoxetine improved HRQoL with respect to placebo in these two domains as assessed by parents (difference between adjusted mean changes and 95% confidence interval, 8.53, 4.05-13.00 and 3.39, 0.13-6.65) and in the risk avoidance domain by patients (3.56, 1.04-6.07). A modest correlation of clinical severity with HRQoL was found in this clinical population.


CONCLUSIONS
This study confirms prior reports the impact of ADHD on the HRQoL of patients as assessed by their parents. The patients' perspective is of a lesser impact. Atomoxetine improved HRQoL as assessed by both parents and patients.
Escobar
Rodrigo
R
EU Medical, Lilly Research Laboratories, Alcobendas, Spain. escobar_rodrigo@lilly.com
Montoya
Alonso
A
Polavieja
Pepa
P
Cardo
Esther
E
Artigas
Josep
J
Hervas
Amaia
A
Fuentes
Joaquín
J
D000293:Adolescent; D018759:Adrenergic Uptake Inhibitors / Q000627:therapeutic use*; D000704:Analysis of Variance; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D010290:Parents / Q000523:psychology; D017060:Patient Satisfaction; D011437:Propylamines / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D011788:Quality of Life; D012720:Severity of Illness Index
D018759:Adrenergic Uptake Inhibitors; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride