Agomelatine as a Treatment for Attention-Deficit/Hyperactivity Disorder in Children and Adolescents: A Double-Blind, Randomized Clinical Trial.
J Child Adolesc Psychopharmacol
; 26(6): 513-9, 2016 08.
Article
em En
| MEDLINE
| ID: mdl-27286139
ABSTRACT
OBJECTIVE:
Attention-deficit/hyperactivity disorder (ADHD) is a chronic neurodevelopmental disorder. Due to lack of response to the medication and significant side effects of the treatment with stimulants, alternative medications should be considered. The aim of this study is to evaluate efficacy of agomelatine in treatment of ADHD.METHODS:
Fifty-four outpatients, children 6-15 years old, with diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria participated in a 6-week, parallel, double-blind, randomized clinical trial. Fifty patients completed 6 weeks of treatment with either ritalin (methylphenidate hydrochloride [MPH]) (20 mg/day in participants below 30 kg and 30 mg/day in patients with weight ≥30 kg) or agomelatine (15 mg/day in patients with weight ≥30 kg and 25 mg/day in patients with weight ≥45 kg). Participants were assessed using Parent and Teacher ADHD Rating Scale-IV at baseline and at weeks 3 and 6.RESULTS:
General linear model repeated measures showed no significant differences between the two groups on Parent and Teacher Rating Scale scores (F = 1.13, df = 1.26, p = 0.305, and F = 0.95, df = 1.25, p = 0.353, respectively). Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the agomelatine group (9.28 ± 8.72 and 24.12 ± 7.04, respectively) and the MPH group (6.64 ± 11.04 and 25.76 ± 7.82, respectively) (p = 0.46 and p = 0.44, respectively). There was a trend for less insomnia in the agomelatine group versus MPH-treated group (4% vs. 24%, p = 0.09).CONCLUSIONS:
A treatment course of 6 weeks with agomelatine demonstrated a favorable safety and efficacy profile in children and adolescents with ADHD. Nonetheless, larger controlled studies with longer treatment periods are necessary.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Transtorno do Deficit de Atenção com Hiperatividade
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Hipnóticos e Sedativos
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Acetamidas
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Metilfenidato
Tipo de estudo:
Clinical_trials
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Guideline
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Prognostic_studies
Limite:
Adolescent
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Child
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Female
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Humans
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Male
Idioma:
En
Revista:
J Child Adolesc Psychopharmacol
Ano de publicação:
2016
Tipo de documento:
Article