Atomoxetine versus methylphenidate in paediatric outpatients with attention deficit hyperactivity disorder: a randomized, double-blind comparison trial.

Full Abstract

OBJECTIVE: To (i) test whether atomoxetine is non-inferior to methylphenidate in treating symptoms of attention deficit hyperactivity disorder (ADHD) in paediatric patients; and (ii) determine the tolerability of the two drugs. METHOD: This double-blind study was conducted in 6- to 16-year-old outpatients with ADHD (DSM-IV) in China, Korea and Mexico (January-October 2004). Patients were randomly assigned to once-daily atomoxetine (0.8-1.8 mg kg(-1) day(-1); n = 164) or twice-daily methylphenidate (0.2-0.6 mg kg(-1) day(-1); n = 166) for approximately 8 weeks. Primary efficacy assessment was the comparison of response rates (> or =40% reduction from baseline to end point in total score) on the Attention Deficit Hyperactivity Disorder Rating Scale-IV-Parent Version: Investigator-Administered and -Scored. Tolerability measures included, but were not limited to, the assessment of treatment-emergent adverse events (TEAEs) and weight. RESULTS: Atomoxetine was non-inferior to methylphenidate in improving ADHD symptoms based on response rates (atomoxetine, 77.4%; methylphenidate, 81.5%; one-sided 95% lower confidence limit = -11.7%, p = 0.404). Treatment-emergent adverse effects experienced significantly more frequently in the atomoxetine group, compared with the methylphenidate group, included anorexia (37.2% vs. 25.3%; p = 0.024), nausea (20.1% vs. 10.2%; p = 0.014), somnolence (26.2% vs. 3.6%; p <0.001), dizziness (15.2% vs. 7.2%; p = 0.024) and vomiting (11.6% vs. 3.6%; p = 0.007), most of which were of mild or moderate severity. Atomoxetine-treated patients experienced a small but significantly greater mean weight loss from baseline to end point than methylphenidate-treated patients (-1.2 kg vs. -0.4 kg; p <0.001). CONCLUSIONS: This study suggests that atomoxetine is non-inferior to methylphenidate in the improvement of ADHD symptoms in paediatric outpatients. Although both of the drugs were well tolerated, atomoxetine was associated with a higher incidence of TEAEs than methylphenidate.

Author information

Author/s: Wang, Yufeng (Y); Zheng, Yi (Y); Du, Yasong (Y); Song, Dong H (DH); Shin, Yee-Jin (YJ); Cho, Soo C (SC); Kim, Bung N (BN); Ahn, Dong H (DH); Marquez-Caraveo, Maria E (ME); Gao, Haitao (H); Williams, David W (DW); Levine, Louise R (LR);

Affiliation: Institute of Mental Health, Beijing Medical University, Beijing, China.

Journal and publication information

Publication Type: Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial

Journal: The Australian and New Zealand journal of psychiatry (Aust N Z J Psychiatry), published in England. (Language: eng)

Reference: 2007-Mar; vol 41 (issue 3) : pp 222-30

Dates: Created 2007/04/27; Completed 2007/05/30;

PMID: 17464703, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Drug Administration Schedule
Female
Humans
Male
Methylphenidate - adverse effects; therapeutic use
Personality Assessment
Propylamines - adverse effects; therapeutic use

Associated Chemicals: Adrenergic Uptake Inhibitors (0) ; Central Nervous System Stimulants (0) ; Propylamines (0) ; Methylphenidate (113-45-1) ; atomoxetine (83015-26-3)

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