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Atomoxetine improves patient and family coping in attention deficit/hyperactivity disorder: a randomized, double-blind, placebo-controlled study in Swedish children and adolescents
European Child and Adolescent Psychiatry, 05/27/09

Svanborg P et al. - Atomoxetine combined with psychoeducation had a positive effect on various everyday coping abilities of the patients as well as their families during 10 weeks of treatment, whereas the patients’ self-image and the parents’ image of the climate in the family were not significantly improved.

Methods

A total of 99 patients were treated with atomoxetine (49 patients) or placebo (50 patients) for 10 weeks and assessed regarding broader areas of functioning using:

the Quality of Life measures Child Health and Illness Profile-Child Edition (CHIP-CE),
Family Strain Index [FSI; equivalent to the Family Burden of Illness Module used in the study],
Appraisal of Stress in Child-Rearing (ASCR),
Five to fifteen (FTF),
“I think I am” (“Jag tycker jag är”),
and Children’s Depression Rating Scale-Revised (CDRS-R) before and after the active treatment phase.

Simultaneously, the patients’ parents participated in a 4-session psychoeducation program.

Results

A statistically significant difference in favor of atomoxetine was seen in the improvement from baseline to study endpoint for the CHIP-CE domains “Achievement” and “Risk avoidance”, for the FSI total score, for the ASCR section (I) domain “Child as a burden”, for all FTF domains except for “Language and Speech”, and for the CDRS-R total score.
No difference between treatment groups was observed in the patient-assessed evaluation of self-esteem using the “I think I am” scale.

Exclusive Author Commentary
Pär Svanborg, 05/31/09

This article is no 2 of 3, describing the QoL results from the 10 weeks double-blind phase of a clincial trial investigating atomoxetine vs. pbo + parental psychoeducation in Swedish stimulant-naïve children and adolescents. The first article was published in Eur Child Adolesc Psychiatry 2009; 18:240–249 DOI 10.1007/s00787-008-0725-5. It describes the effect on core ADHD symptoms, the safety profile and the psychoeducation itself. This study has shown the so far highest effect size of an atomoxtine trail ever (ES=1.3). A third article, published in Journal of Attention Disorders OnlineFirst, April 13, 2009 as doi:10.1177/1087054709332163 reported of the health economic part of the double-blind period, but also of the long-term follow up period, when all patients could openly continue with active treatment up to 9 months, or until atomoxetine became commercially available in Sweden. This article presents preliminary evidence that atomoxetine together with parental psychoeducation reduces nonmedication costs associated with ADHD. Further articles from this trial are planned, decribing the development of core ADHD symptoms, and different measures of QoL, family functioning, neurpsychiatric functioning, and patients' self-esteem during the long-term follow up period.

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