Abstract:
OBJECTIVE:To test the hypothesis that first-line treatment with atomoxetine provides superior efficacy than placebo for up to 12 weeks in improving the symptoms of Attention Deficit/Hyperactivity Disorder (ADHD). RESEARCH DESIGN AND METHODS:This double-blind, randomized, placebo-controlled, parallel clinical trial included 151 treatment-naïve children (n = 113) and adolescents (n = 38) with newly diagnosed (< or =3 months) ADHD. Atomoxetine dose was uptitrated from 0.5 to 1.2 mg/kg/day after two weeks. Outcome assessments included the ADHD Rating Scale-IV-Parent-reported Investigator-rated (ADHDRS-IV-Parent:Inv), the Clinical Global Impression of Severity of ADHD (CGI-ADHD-S), and the incidence of adverse events. Mixed-model repeated measures analysis was used to compare scale score changes between groups. CLINICAL TRIAL REGISTRATION:Trial registered at www.clinicaltrials.gov (study internal code: B4Z-XM-LYDM, identifier: NCT00191945). RESULTS:Most patients were male (79.2%), of caucasian origin (96.0%) and severely ill (72.5%). Their mean age was 10.3 years. Atomoxetine-treated patients showed greater reductions from baseline to week 12 of total ADHDRS-IV-Parent:Inv score than placebo-treated patients (least square mean difference: -7.9 [95% CI: -11.0 to -4.8], corresponding to a large effect size of 0.8). Between-group mean differences increased progressively with treatment exposure from week 6 to 12 (-2.7 [-4.9 to -0.6] for total and -1.6 [-2.9 to -0.3] for inattention scores). At the end of the study, 50% of atomoxetine-treated patients (14% with placebo) showed a reduction > or =40% in total ADHDRS-IV-Parent:Inv score, and only 29% (46% with placebo) were severely ill (by CGI-ADHD-S). Treatment-related adverse events were significantly more frequent with atomoxetine (65.0%) than with placebo (37.3%), the most frequent being decreased appetite and somnolence. Only one case of decreased appetite was rated as severe. No patient discontinued treatment because of adverse events. CONCLUSIONS:A continued improvement of symptoms is expectable until 12 weeks in treatment-naïve ADHD patients treated with atomoxetine as first-line medication. Chief limitations are the small, national sample size and the absence of data beyond the 12-week time-point.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Montoya A,Hervas A,Cardo E,Artigas J,Mardomingo MJ,Alda JA,Gastaminza X,García-Polavieja MJ,Gilaberte I,Escobar Rdoi
10.1185/03007990903316152subject
Has Abstractpub_date
2009-11-01 00:00:00pages
2745-54issue
11eissn
0300-7995issn
1473-4877journal_volume
25pub_type
杂志文章,多中心研究,随机对照试验abstract::A double-blind, parallel-group study was carried out to compare the efficacy and tolerability of a controlled-release tablet formulation of trazodone with the standard trazodone tablet. Three hundred and forty-seven general practice patients with depressive symptoms were recruited into the trial. Patients were randoml...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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journal_title:Current medical research and opinion
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