Results From 2 Proof-of-Concept, Placebo-Controlled Studies of Atomoxetine in Children With Attention-Deficit/Hyperactivity Disorder

Autor: John H. Heiligenstein, Joseph Biederman, Christopher J. Kratochvil, William Z. Potter, Douglas E. Faries, Thomas J. Spencer, C. Keith Conners
Rok vydání: 2002
Předmět:
Zdroj: The Journal of Clinical Psychiatry. 63:1140-1147
ISSN: 0160-6689
DOI: 10.4088/jcp.v63n1209
Popis: Background: Atomoxetine is a nonstimulant drug being studied for the treatment of attention-deficit/hyperactivity disorder (ADHD). Atomoxetine is a highly specific inhibitor of the presynaptic norepinephrine transporter with minimal affinity for other noradrenergic receptors or other neurotransmitter transporters or receptors. Results of 2 proof-of-concept studies are reported that tested the hypothesis that a selective inhibitor of presynaptic norepinephrine uptake would be effective for the treatment of ADHD in school-aged children. Method: Two identical 12-week, stratified, randomized, double-blind, placebo-controlled trials were conducted in children who met DSM-IV criteria for ADHD. The primary efficacy outcome measure was the mean change from baseline to endpoint in the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD RS) total score. Secondary efficacy measures included the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) and the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S). Results: A total of 291 patients were randomized in the 2 trials combined (Study 1, N = 147; Study 2, N = 144). Stimulant-naive patients were randomized to atomoxetine, placebo, or methylphenidate. Patients with prior stimulant exposure were randomized to atomoxetine or placebo. Atomoxetine significantly reduced ADHD RS total scores compared with placebo in each study (p
Databáze: OpenAIRE