Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in stimulant-naïve Swedish children and adolescents.
OBJECTIVE
The primary objective of this study was to assess the impact of atomoxetine in combination with psychoeducation, compared with placebo and psychoeducation, on health-related quality of life (HRQL) in Swedish stimulant-naïve pediatric patients with attention deficit/hyperactivity disorder (ADHD). HRQL results will be presented elsewhere. Here, psychoeducation as well as efficacy and safety of the treatment are described.


METHODS
A total of 99 pediatric ADHD patients were randomized to a 10-week double-blind treatment with atomoxetine (49 patients) or placebo (50 patients). Parents of all patients received four sessions of psychoeducation. Atomoxetine was dosed up to approximately 1.2 mg/kg day (< or = 70 kg) or 80 mg/day (> 70 kg). Improvement of ADHD symptoms was evaluated using the ADHD rating scale (ADHD-RS) and clinical global impression (CGI) rating scales. Safety was assessed based on adverse events (AEs).


RESULTS
The study population was predominantly male (80.8%) and diagnosed with the combined ADHD subtype (77.8%). The least square mean (lsmean) change from baseline to endpoint in total ADHD-RS score was -19.0 for atomoxetine patients and -6.3 for placebo patients, resulting in an effect size (ES) of 1.3 at endpoint. Treatment response (reduction in ADHD-RS score of > or = 25 or > or = 40%) was achieved in 71.4 or 63.3% of atomoxetine patients and 28.6 or 14.3% of placebo patients. The lsmean change from baseline to endpoint in CGI-Severity was -1.8 in the atomoxetine group compared with -0.3 in the placebo group. The difference between treatments in CGI-Improvement at endpoint was -1.4 in favor of atomoxetine. No serious AEs occurred. The safety profile of atomoxetine was in line with the current label.


CONCLUSIONS
Atomoxetine combined with psychoeducation was superior to placebo and psychoeducation in ADHD core symptoms improvement. The large ES might be a result of including stimulant-naïve patients only, but also may indicate a positive interaction between atomoxetine treatment and psychoeducation, possibly by increased compliance.
Svanborg
Pär
P
Eli Lilly Sweden AB, Gustav III Boulevard 42, Box 721, 169 27, Solna, Sweden. svanborg_par@lilly.com
Thernlund
Gunilla
G
Gustafsson
Per A
PA
Hägglöf
Bruno
B
Poole
Lynne
L
Kadesjö
Björn
B
D000293:Adolescent; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000453:epidemiology; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008603:Mental Health; D010353:Patient Education as Topic; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology; D011795:Surveys and Questionnaires; D013548:Sweden / Q000453:epidemiology
D000697:Central Nervous System Stimulants; D011437:Propylamines; D000069445:Atomoxetine Hydrochloride