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A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD

Identifieur interne : 00AE04 ( Main/Exploration ); précédent : 00AE03; suivant : 00AE05

A prospective, multicenter, open-label assessment of atomoxetine in non-North American children and adolescents with ADHD

Auteurs : Jan K. Buitelaar [Pays-Bas] ; Marina Danckaerts [Belgique] ; Christopher Gillberg [Suède] ; Alessandro Zuddas [Italie] ; Katja Becker [Allemagne] ; Manuel Bouvard [France] ; Jenny Fagan [Afrique du Sud] ; Julia Gadoros [Hongrie] ; Valerie Harpin [Royaume-Uni] ; Philip Hazell [Australie] ; Mats Johnson [Suède] ; Tally Lerman-Sagie [Israël] ; Cesar A. Soutullo [Espagne] ; Tomasz Wolanczyk [Pologne] ; Pal Zeiner [Norvège] ; Daniel S. Fouche [États-Unis, Pays-Bas] ; Judith Krikke-Workel [États-Unis, Pays-Bas] ; Shuyu Zhang [États-Unis, Pays-Bas] ; David Michelson [États-Unis, Pays-Bas]

Source :

RBID : Pascal:04-0603761

Descripteurs français

English descriptors

Abstract

Objective The aim of this study was to study treatment response to atomoxetine in a large, multicenter study of non-North American patients with ADHD. Methods A total of 604 children and adolescents with ADHD were enrolled in a 10-week open-label trial with atomoxetine prior to randomization to a double-blind relapse prevention phase at 33 sites in the United Kingdom, continental Europe, Israel, South Africa, and Australia. All patients had ADHD symptom severity at least 1.5 standard deviations above United States age and gender norms for their diagnostic subtype as measured by the investigator-scored ADHD Rating Scale (ADHD RS). Outcomes were assessed by analysis of change in the ADHD RS; functional and psychosocial outcomes were assessed using the Child Health Questionnaire (CHQ). Results At endpoint, ADHD RS total scores decreased by an average of 56.7 %, and 69 % of patients were rated as having no or minimal symptoms. Significant improvement was observed in psychosocial and functional outcomes. Discontinuations attributed to adverse events were < 4 %. Conclusion These open-label data, gathered in an international setting, add to our knowledge of the value of atomoxetine in treating ADHD symptoms, as well as its safety and tolerability.


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Le document en format XML

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<name sortKey="Zhang, Shuyu" sort="Zhang, Shuyu" uniqKey="Zhang S" first="Shuyu" last="Zhang">Shuyu Zhang</name>
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<s1>Lilly Research Laboratories</s1>
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<name sortKey="Michelson, David" sort="Michelson, David" uniqKey="Michelson D" first="David" last="Michelson">David Michelson</name>
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<series>
<title level="j" type="main">European child & adolescent psychiatry</title>
<title level="j" type="abbreviated">Eur. child adolesc. psychiatry</title>
<idno type="ISSN">1018-8827</idno>
<imprint>
<date when="2004">2004</date>
</imprint>
</series>
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<seriesStmt>
<title level="j" type="main">European child & adolescent psychiatry</title>
<title level="j" type="abbreviated">Eur. child adolesc. psychiatry</title>
<idno type="ISSN">1018-8827</idno>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Adolescent</term>
<term>Atomoxetine</term>
<term>Attentional disorder</term>
<term>Behavioral disorder</term>
<term>Chemotherapy</term>
<term>Child</term>
<term>Concomitant disease</term>
<term>Hyperactivity</term>
<term>Mental disorder</term>
<term>Treatment efficiency</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Trouble attention</term>
<term>Hyperactivité</term>
<term>Efficacité traitement</term>
<term>Atomoxétine</term>
<term>Chimiothérapie</term>
<term>Association morbide</term>
<term>Trouble comportement</term>
<term>Trouble psychiatrique</term>
<term>Enfant</term>
<term>Adolescent</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Enfant</term>
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<front>
<div type="abstract" xml:lang="en">Objective The aim of this study was to study treatment response to atomoxetine in a large, multicenter study of non-North American patients with ADHD. Methods A total of 604 children and adolescents with ADHD were enrolled in a 10-week open-label trial with atomoxetine prior to randomization to a double-blind relapse prevention phase at 33 sites in the United Kingdom, continental Europe, Israel, South Africa, and Australia. All patients had ADHD symptom severity at least 1.5 standard deviations above United States age and gender norms for their diagnostic subtype as measured by the investigator-scored ADHD Rating Scale (ADHD RS). Outcomes were assessed by analysis of change in the ADHD RS; functional and psychosocial outcomes were assessed using the Child Health Questionnaire (CHQ). Results At endpoint, ADHD RS total scores decreased by an average of 56.7 %, and 69 % of patients were rated as having no or minimal symptoms. Significant improvement was observed in psychosocial and functional outcomes. Discontinuations attributed to adverse events were < 4 %. Conclusion These open-label data, gathered in an international setting, add to our knowledge of the value of atomoxetine in treating ADHD symptoms, as well as its safety and tolerability.</div>
</front>
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<li>Allemagne</li>
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<li>France</li>
<li>Hongrie</li>
<li>Israël</li>
<li>Italie</li>
<li>Norvège</li>
<li>Pays-Bas</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>Suède</li>
<li>États-Unis</li>
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<li>Aquitaine</li>
<li>Communauté forale de Navarre</li>
<li>Hongrie centrale</li>
<li>Nouvelle-Aquitaine</li>
<li>Province du Brabant flamand</li>
<li>Østlandet</li>
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<li>Budapest</li>
<li>Louvain</li>
<li>Oslo</li>
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