A randomized, waiting list-controlled 12-week trial of atomoxetine in adults with ADHD

Pharmacopsychiatry. 2012 May;45(3):100-7. doi: 10.1055/s-0031-1291319. Epub 2011 Dec 15.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adrenergic Uptake Inhibitors / administration & dosage*
  • Adrenergic Uptake Inhibitors / adverse effects
  • Adult
  • Atomoxetine Hydrochloride
  • Attention Deficit Disorder with Hyperactivity / drug therapy*
  • Attention Deficit Disorder with Hyperactivity / psychology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Propylamines / administration & dosage*
  • Propylamines / adverse effects
  • Quality of Life
  • Self Concept
  • Treatment Outcome
  • Waiting Lists
  • Young Adult

Substances

  • Adrenergic Uptake Inhibitors
  • Propylamines
  • Atomoxetine Hydrochloride