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 |
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Rok vydání: | 2002 |
Předmět: |
Male
medicine.medical_specialty Population Atomoxetine Hydrochloride Placebo Norepinephrine uptake Double-Blind Method Internal medicine mental disorders medicine Humans Attention deficit hyperactivity disorder Child Psychiatry education education.field_of_study Propylamines biology Methylphenidate Atomoxetine medicine.disease Antidepressive Agents Psychiatry and Mental health Treatment Outcome Norepinephrine transporter Attention Deficit Disorder with Hyperactivity biology.protein Female Psychology medicine.drug Atomoxetine hydrochloride |
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 |
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