dc.contributor.author | Svanborg, Pär | de |
dc.contributor.author | Thernlund, Gunilla | de |
dc.contributor.author | Gustafsson, Per A. | de |
dc.contributor.author | Hägglöf, Bruno | de |
dc.contributor.author | Poole, Lynne | de |
dc.contributor.author | Kadesjö, Björn | de |
dc.date.accessioned | 2010-07-15T14:08:00Z | de |
dc.date.accessioned | 2012-08-29T23:03:38Z | |
dc.date.available | 2012-08-29T23:03:38Z | |
dc.date.issued | 2009 | de |
dc.identifier.uri | http://www.ssoar.info/ssoar/handle/document/12362 | |
dc.description.abstract | 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 (≤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 ≥25 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. | en |
dc.language | en | de |
dc.subject.ddc | Psychology | en |
dc.subject.ddc | Psychologie | de |
dc.subject.other | ADHD; atomoxetine; clinical research/trial; parenting education; pharmacotherapy | |
dc.title | Efficacy and safety of atomoxetine as add-on to psychoeducation in the treatment of attention deficit/ hyperactivity disorder | en |
dc.description.review | begutachtet (peer reviewed) | de |
dc.description.review | peer reviewed | en |
dc.source.journal | European Child & Adolescent Psychiatry | de |
dc.source.volume | 18 | de |
dc.publisher.country | DEU | |
dc.source.issue | 4 | de |
dc.subject.classoz | Psychological Testing, Psychological Counseling, Psychological Methodology | en |
dc.subject.classoz | Psychological Disorders, Mental Health Treatment and Prevention | en |
dc.subject.classoz | psychologische Diagnostik und Beratung, psychologische Methoden | de |
dc.subject.classoz | psychische Störungen, Behandlung und Prävention | de |
dc.identifier.urn | urn:nbn:de:0168-ssoar-123620 | de |
dc.date.modified | 2010-07-27T11:44:00Z | de |
dc.rights.licence | PEER Licence Agreement (applicable only to documents from PEER project) | de |
dc.rights.licence | PEER Licence Agreement (applicable only to documents from PEER project) | en |
ssoar.gesis.collection | SOLIS;ADIS | de |
ssoar.contributor.institution | http://www.peerproject.eu/ | de |
internal.status | 3 | de |
dc.type.stock | article | de |
dc.type.document | journal article | en |
dc.type.document | Zeitschriftenartikel | de |
dc.rights.copyright | f | de |
dc.source.pageinfo | 240-249 | |
internal.identifier.classoz | 10707 | |
internal.identifier.classoz | 10708 | |
internal.identifier.journal | 111 | de |
internal.identifier.document | 32 | |
internal.identifier.ddc | 150 | |
dc.identifier.doi | https://doi.org/10.1007/s00787-008-0725-5 | de |
dc.description.pubstatus | Published Version | en |
dc.description.pubstatus | Veröffentlichungsversion | de |
internal.identifier.licence | 7 | |
internal.identifier.pubstatus | 1 | |
internal.identifier.review | 1 | |
internal.check.abstractlanguageharmonizer | CERTAIN | |
internal.check.languageharmonizer | CERTAIN_RETAINED | |