Quality of life and attention-deficit/hyperactivity disorder core symptoms: a pooled analysis of 5 non-US atomoxetine clinical trials.

The objective of this pooled analysis was to correlate parameters related to quality of life with attention-deficit/hyperactivity disorder (ADHD) core symptoms analyzing data of 5 atomoxetine clinical trials in children and adolescents with ADHD. Data from 5 clinical trials (4 from Europe and 1 from Canada) with similar inclusion/exclusion criteria and similar duration (8-12 weeks' follow-up) were included. All studies used the Child Health and Illness Profile, Child Edition (CHIP-CE), parent rating form at baseline and end point. Correlation coefficients and effect sizes to ADHD-Rating Scale (ADHD-RS) scores were calculated. A total of 794 patients aged 6 to 15 years (mean, 9.7 years), with mean (SD) baseline Clinical Global Impression of Severity of 4.8 (0.89) and ADHD-RS of 41.8 (8.04), were included. Baseline total CHIP-CE mean t score (standard, 50 [10]) was 28.9 (11.76), and the strongest impairments were seen in risk avoidance (30.2 [14.62]) and achievement (30.5 [10.4]) domains. At baseline, CHIP-CE versus ADHD-RS correlation was low (total, -0.345) except for the risk avoidance domain (total, -0.517). For changes from baseline to end point, a low correlation between the scales was found (total, -0.364; placebo-controlled studies only, n = 372). Quality of life impairment in ADHD was found in CHIP-CE total score and several domains. Correlations between CHIP-CE and ADHD-RS at baseline, end point, and for change from baseline to end point were low to moderate. These findings suggest that measuring quality of life adds clinically relevant insight beyond core symptom evaluation in children and adolescents with ADHD.