PMID- 19156355
OWN - NLM
STAT- MEDLINE
DCOM- 20090713
LR  - 20220310
IS  - 1435-165X (Electronic)
IS  - 1018-8827 (Linking)
VI  - 18
IP  - 4
DP  - 2009 Apr
TI  - 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-naive Swedish children and adolescents.
PG  - 240-9
LID - 10.1007/s00787-008-0725-5 [doi]
AB  - 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-naive 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-naive patients 
      only, but also may indicate a positive interaction between atomoxetine treatment 
      and psychoeducation, possibly by increased compliance.
FAU - Svanborg, Par
AU  - Svanborg P
AD  - Eli Lilly Sweden AB, Gustav III Boulevard 42, Box 721, 169 27, Solna, Sweden. 
      svanborg_par@lilly.com
FAU - Thernlund, Gunilla
AU  - Thernlund G
FAU - Gustafsson, Per A
AU  - Gustafsson PA
FAU - Hagglof, Bruno
AU  - Hagglof B
FAU - Poole, Lynne
AU  - Poole L
FAU - Kadesjo, Bjorn
AU  - Kadesjo B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090120
PL  - Germany
TA  - Eur Child Adolesc Psychiatry
JT  - European child & adolescent psychiatry
JID - 9212296
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Propylamines)
RN  - 57WVB6I2W0 (Atomoxetine Hydrochloride)
SB  - IM
MH  - Adolescent
MH  - Atomoxetine Hydrochloride
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy/epidemiology
MH  - Central Nervous System Stimulants/*therapeutic use
MH  - Child
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - *Mental Health
MH  - *Patient Education as Topic
MH  - Propylamines/adverse effects/*therapeutic use
MH  - Quality of Life/psychology
MH  - Surveys and Questionnaires
MH  - Sweden/epidemiology
EDAT- 2009/01/22 09:00
MHDA- 2009/07/14 09:00
CRDT- 2009/01/22 09:00
PHST- 2007/12/04 00:00 [received]
PHST- 2008/08/10 00:00 [accepted]
PHST- 2009/01/22 09:00 [entrez]
PHST- 2009/01/22 09:00 [pubmed]
PHST- 2009/07/14 09:00 [medline]
AID - 10.1007/s00787-008-0725-5 [doi]
PST - ppublish
SO  - Eur Child Adolesc Psychiatry. 2009 Apr;18(4):240-9. doi: 
      10.1007/s00787-008-0725-5. Epub 2009 Jan 20.