Objective: Attention Deficit Hyperactivity Disorder (ADHD) is an important neuropsychological developmental disorder characterized by the presence of impaired attention, impulsivity and hyperactivity. In most cases, ADHD extends through adolescence and persists during adult age; hence, its treatment is often carried-out for long time periods. One of the drugs used to treat such disorder is atomoxetine, a selective noradrenaline re-uptake inhibitor. Acute atomoxetine efficacy has been extensively evaluated through numerous placebo-controlled trials. This study aims at testing the efficacy and safety of long-term atomoxetine use. Methods: In this international multicentre trial, 6-15 years-old children and adolescents with a DSM-IV diagnosis of ADHD were involved. All subjects were treated in an open-label basis for about 12 weeks with flexible-dosage atomoxetine. Patients who obtained symptom remission were randomly assigned to further 9 months of double-blind treatment with atomoxetine or placebo (Fig. 1). During the open-label phase, 604 patients were enrolled. Of these patients, 416 were considered responders and proceeded to the extension phase of double-blind atomoxetine vs. placebo, to assess the ability of the drug to prevent relapses. Results: Atomoxetine confirmed its efficacy in acutely improving ADHD symptoms, as shown by the statistically significant (p <0.001) reduction of ADHD-RS-IV scores (Fig. 2). Of the initial 604 patients, 416 (69%) were considered responders. Atomoxetine was superior to placebo in long term in preventing relapses, which occurred significantly less in the group of patients receiving atomoxetine with respect to the group receiving placebo (Figg. 3, 4). The effect of atomoxetine was superior to that of placebo also in some secondary outcomes, such as psychosocial functioning. The drug's safety and tolerability were similar to those observed during acute, short-term studies (Tab. III). Conclusions: The results of this study provide evidence of the efficacy of atomoxetine in maintenance treatment of paediatric patients affected by ADHD. The effect on psychosocial functioning as well as that obtained on core symptoms of ADHD seems to extend also in the long-term treatment period.
|Translated title of the contribution||Results of a long-term trial of the use of atomoxetine in the relapse prevention in pediatric patients with ADHD|
|Number of pages||7|
|Journal||Italian Journal of Psychopathology|
|Publication status||Published - Jun 2005|
ASJC Scopus subject areas
- Psychiatry and Mental health