Evaluation of Patients' and Parents' Quality of Life in a Randomized Placebo-Controlled Atomoxetine Study in Attention-Deficit/Hyperactivity Disorder

Abstract

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).

Method:

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.

Registry:

This study is registered at http://www.clinicaltrials.gov (identifier: NCT00191945).