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
Open accessAbstract
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.Patients and 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.
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Atomoxetine efficacy has been confirmed in populations around the world, including for children with oppositional defiant disorder or those who have received previous stimulant therapy.
“studies in populations around the world have continued to confirm its efficacy [78-81], including for children with oppositional defiant disorder [82] or those who have received previous stimulant therapy [83].”
From Advances in understanding and treating ADHD (2011) · cites this paper as [78]
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References 37 · Cited by 71
Research works printed but not linked: 2
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- Authors
- Svanborg, P., Thernlund, G., Gustafsson, P. A., Hägglöf, B., Poole, L., & Kadesjö, B.
- Affiliations
- Karolinska Institutet (SE)
- Lund University (SE)
- Linköping University Hospital (SE)
- Umeå University (SE)
- Drottning Silvias barn- och ungdomssjukhus (SE)
- Corresponding author
- Svanborg, Pär
- ORCID
- Kadesjö, Björn
- Venue
- European Child & Adolescent Psychiatry
- Published
- 2009-01-20
- Volume
- 18
- Issue
- 4
- Pages
- 240-249
- ISSN
- 1018-8827 (ISSN-L)
- 1435-165X
- OpenAlex
- W2073229941
- Cited by
- 71
- References
- 37
- Citations by year
- 2025: 2 · 2024: 1 · 2023: 1 · 2022: 1 · 2020: 2 · 2019: 2 · 2017: 4 · 2016: 6 · 2015: 9 · 2014: 6 · 2013: 7 · 2012: 8
- FWCI
- 6.17
- Type
- journal article
- Language
- en
- Open access
- green
- hal.science
- Licence
- other-oa
- www.springer.com/tdm (tdm)
- Locations
- European Child & Adolescent Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- HAL (submittedVersion, other-oa)
- Social Science Open Access Repository (GESIS – Leibniz Institute for the Social Sciences) (submittedVersion)
- Lund University Publications (Lund University) (submittedVersion)
- Trinity's Access to Research Output (TARA) (Trinity College Dublin) (submittedVersion)
- Funders
- Eli Lilly and Company
- Lilly Deutschland
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- atomoxetine, attention deficit hyperactivity disorder, psychoeducation, ADHD symptom improvement, treatment efficacy, drug safety, adverse events, parent training, medication adherence
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Double-Blind Method, Female, Humans, Male, Mental Health, Patient Education as Topic, Propylamines, Quality of Life, Surveys and Questionnaires, Sweden
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