A Randomized, Waiting List-Controlled 12-Week Trial of Atomoxetine in Adults with ADHD

BACKGROUND: With the increasing recognition of adult attention-deficit/hyperactivity disorder (ADHD) there is an emerging need to investigate medication in this population. METHODS: 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 (CAARSO: L DSM-IV total ADHD score) from baseline to endpoint. Other efficacy measures included selfrated CAARS-S:L DSM-IV total ADHD score, CAARS-O/S:L problems with self-concept and emotional lability score, Wender-Reimherr Adult Attention Defi cit 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. RESULTS: 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. DISCUSSION: Our results suggest that Atx is an effective treatment in adult ADHD. It reduces ADHD core and associated emotional symptoms and increases self-esteem and quality of life. AEs were consistent with those reported in other studies in adult ADHD.