An Open-label, Self-control, Prospective Study on Cognitive Function, Academic Performance, and Tolerability of Osmotic-release Oral System Methylphenidate in Children with Attention-deficit Hyperactivity Disorder / 中华医学杂志(英文版)
Chinese Medical Journal
; (24): 2988-2997, 2015.
Artigo
em Inglês
| WPRIM (Pacífico Ocidental)
| ID: wpr-275577
Biblioteca responsável:
WPRO
ABSTRACT
<p><b>BACKGROUND</b>Attention-deficit hyperactivity disorder (ADHD) is the most common mental and behavioral disorder in school-aged children. This study evaluated the effect of osmotic-release oral system (OROS) methylphenidate (MPH) on cognitive function and academic performance of Chinese school-aged children with ADHD.</p><p><b>METHODS</b>This 12-week, prospective, multicenter, open-label, self-controlled study enrolled 153 Chinese school-aged children with ADHD and 41 non-ADHD children. Children with ADHD were treated with once-daily OROS-MPH (18 mg, 36 mg, or 54 mg). The primary endpoints were Inattention/Overactivity (I/O) with Aggression Conners Behavior Rating Scale (IOWA) and Digit Span Test at week 12 compared with baseline. Secondary endpoints included opposition/defiant (O/D) subscale of IOWA, Clinical Global Impression (CGI), Coding Test, Stroop Color-word Test, Wisconsin Card Sorting Test (WCST), academic performance on teacher-rated school examinations, and safety at week 12 compared with baseline. Both non-ADHD and ADHD children received the same frequency of cognitive operational test to avoid the possible bias caused by training.</p><p><b>RESULTS</b>A total of 128 patients were evaluated with cognitive assessments. The OROS-MPH treatment significantly improved IOWA Conners I/O subscale scores at week 12 (3.8 ± 2.3) versus baseline (10.0 ± 2.4; P < 0.0001). Digit Span Test scores improved significantly (P < 0.0001) with a high remission rate (81.1%) at week 12 versus baseline. A significant (P < 0.0001) improvement was observed in O/D subscale of IOWA, CGI, Coding Test, Stroop Color-word Test, WCST, and academic performance at week 12 versus baseline. Very few practice-related improvements were noticed in the non-ADHD group at week 12 compared with baseline. No serious adverse events and deaths were reported during the study.</p><p><b>CONCLUSIONS</b>The OROS-MPH treatment effectively controlled symptoms of ADHD and significantly improved academic performance and cognitive function of Chinese school-aged children with ADHD. The treatment was found to be safe and generally well-tolerated over 12 weeks.</p><p><b>TRIAL REGISTRATION</b>ClinicalTrials.gov, NCT01933880; http//clinicaltrials.gov/ct2/show/NCT01933880?term=CONCERTAATT4099&rank=1.</p>
Texto completo:
Disponível
Contexto em Saúde:
Agenda de Saúde Sustentável para as Américas
/
ODS3 - Saúde e Bem-Estar
/
ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
Problema de saúde:
Objetivo 9: Redução de doenças não transmissíveis
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Meta 3.2: Reduzir as mortes de recém nascidos e crianças com menos de 5 anos
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Saúde Mental e Transtornos do Comportamento
Base de dados:
WPRIM (Pacífico Ocidental)
Assunto principal:
Transtorno do Deficit de Atenção com Hiperatividade
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Administração Oral
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Estudos Prospectivos
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Resultado do Tratamento
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Cognição
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Usos Terapêuticos
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Tratamento Farmacológico
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Metilfenidato
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Testes Neuropsicológicos
Tipo de estudo:
Ensaio clínico controlado
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Estudo observacional
Limite:
Criança
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Feminino
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Humanos
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Masculino
Idioma:
Inglês
Revista:
Chinese Medical Journal
Ano de publicação:
2015
Tipo de documento:
Artigo