Impairments of health related quality of life (HR-QoL), as well as effective treatment options, including atomoxetine, are well documented in Attention Deficit/Hyperactivity Disorder (ADHD).

To identify prognostic factors of improvement in HR-QoL in children and adolescents with ADHD, after atomoxetine treatment, as measured by the Child Health and Illness Profile- Child Edition Parent Report Form (CHIP-CE PRF) Achievement (A) and Risk Avoidance (RA) domains.

Pooled data from children and adolescents with ADHD treated with atomoxetine from 3 placebo controlled and separate data from 3 open-label trials were analyzed using logistic regression methodology. Only subjects impaired at baseline in the CHIP-CE PRF A and RA domains with < 40 points were included (n = 190 and 183 in the double-blind pooled sample; 422 and 355 from the open-label studies, respectively). Treatment outcome after 8–16 weeks was categorised as < 2.5 points change, between 2.5 and 10 points or more than 10 points change.

Based on data of the pooled sample of double-blind studies, baseline impairment in CHIP-CE sub-domains and study (overall study effect: p < 0.001) were associated with treatment outcome for both outcome domains, while having early Treatment Emergent Adverse Events (OR: 2.0) was associated with improved outcome on the RA domain. Additionally, across the 3 open-label studies, initial symptom response (OR: 3.2–15.6) was most robustly associated with treatment outcome.

Baseline impairment in HR-QoL as well as initial treatment response may be prognostic factors of atomoxetine treatment outcome in HR-QoL in children and adolescents with ADHD.