An Open-Label, Randomized Trial of Methylphenidate and Atomoxetine Treatment in Children with Attention-Deficit/Hyperactivity Disorder
| Autor: | Yi-Lei Pan, Susan Shur-Fen Gau, Hsiang-Yuan Lin, Lin-Wan Huang, Chi-Yung Shang |
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| Rok vydání: | 2015 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Adolescent Medication adherence Atomoxetine Hydrochloride behavioral disciplines and activities Medication Adherence law.invention Randomized controlled trial law mental disorders medicine Humans Attention deficit hyperactivity disorder Pharmacology (medical) Child Psychiatry Psychiatric Status Rating Scales Methylphenidate Atomoxetine medicine.disease Clinical trial Psychiatry and Mental health Treatment Outcome Attention Deficit Disorder with Hyperactivity Pediatrics Perinatology and Child Health Psychiatric status rating scales Central Nervous System Stimulants Female Open label Psychology medicine.drug |
| Zdroj: | Journal of Child and Adolescent Psychopharmacology. 25:566-573 |
| ISSN: | 1557-8992 1044-5463 |
| DOI: | 10.1089/cap.2015.0035 |
| Popis: | The efficacy of both methylphenidate and atomoxetine has been established in placebo-controlled trials. The present study aimed to directly compare the efficacy of methylphenidate and atomoxetine in improving symptoms among children with attention-deficit/hyperactivity disorder (ADHD).The study sample included 160 drug-naïve children and adolescents 7-16 years of age, with DSM-IV-defined ADHD, randomly assigned to osmotic-release oral system methylphenidate (OROS-methylphenidate) (n=80) and atomoxetine (n=80) in a 24 week, open-label, head-to-head clinical trial. The primary efficacy measure was the score of the ADHD Rating Scale-IV Parents Version: Investigator Administered and Scored (ADHD-RS-IV). The secondary efficacy measures included the Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) and Chinese Swanson, Nolan, and Pelham IV scale (SNAP-IV), based on the ratings of investigators, parents, teachers, and subjects.At week 24, mean changes in ADHD-RS-IV Inattention scores were 13.58 points (Cohen's d, -3.08) for OROS-methylphenidate and 12.65 points (Cohen's d, -3.05) for atomoxetine; and mean changes in ADHD-RS-IV Hyperactivity-Impulsivity scores were 10.16 points (Cohen's d, -1.75) for OROS-methylphenidate and 10.68 points (Cohen's d, -1.87) for atomoxetine. In terms of parent-, teacher-, and self-ratings on behavioral symptoms, both of the two treatment groups significantly decreased on the SNAP-IV scores at the end-point, with effect sizes ranging from 0.9 to 0.96 on the Inattention subscale and from 0.61 to 0.8 on the Hyperactivity/Impulsivity subscale for OROS-methylphenidate; and from 0.51 to 0.88 on the Inattention subscale and from 0.29 to 0.57 on the Hyperactivity/Impulsivity subscale for atomoxetine. No statistically significant differences between treatment groups were observed on the outcome measures. Vomiting, somnolence, and dizziness were reported more often for atomoxetine than for OROS-methylphenidate, whereas insomnia was reported more often for OROS-methylphenidate than for atomoxetine.After 24 weeks of treatment, OROS-methylphenidate and atomoxetine had comparable efficacy in reducing core ADHD symptoms in drug-naïve children and adolescents with ADHD. |
| Databáze: | OpenAIRE |
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