A Randomized, Waiting List-Controlled 12-Week Trial of Atomoxetine in Adults with ADHD
Pharmacopsychiatry, 05/17/2012Sobanski E et al.
The results suggest that atomoxetine is an effective treatment in adult attention–deficit/hyperactivity disorder (ADHD). It reduces ADHD core and associated emotional symptoms and increases self–esteem and quality of life. Adverse events were consistent with those reported in other studies in adult ADHD.
In this waiting list-controlled trial, 64 ADHD-patients (mean age 35.8±8.7 years) were randomly assigned to a daily dosage of up to 80 mg atomoxetine (Atx) or waiting list for 12-weeks.
Primary outcome was the change of the observer-rated DSM-IV total ADHD score on the Conners' Adult ADHD Rating Scales (CAARS-O:L DSM-IV total ADHD score) from baseline to endpoint.
Other efficacy measures included self-rated CAARS-S:L DSM-IV total ADHD score, CAARS-O/S:L problems with self-concept and emotional lability score, Wender-Reimherr Adult Attention Deficit Disorder Scale Emotional Dysregulation Score, and General Activities Score on the Quality of Life Enjoyment and Satisfaction Questionnaire.
Efficacy measures were analysed in the per-protocol population.
Mean change in CAARS:O-L DSM-IV total ADHD score was - 13.1±7.7 in the Atx vs. - 0.4±4.8 in the control group (p<0.005).
Treatment response (≥30% reduction) was 60.1% in the Atx vs. 0% in the waiting list group.
The other efficacy measures also showed significant improvements.
The overall incidence of adverse events (AEs) was 70.4% in the Atx group, the most frequent included fatigue, irritability, nausea and decreased appetite.
In Atx-treated patients 18.5% discontinued early due to AEs.
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