A pilot study for augmenting atomoxetine with methylphenidate: Safety of concomitant therapy in children with attention-deficit/hyperactivity disorder

被引:32
作者
Carlson G.A. [1 ]
Dunn D. [2 ]
Kelsey D. [3 ]
Ruff D. [3 ]
Ball S. [3 ]
Ahrbecker L. [3 ]
Allen A.J. [3 ]
机构
[1] Department of Child and Adolescent Psychiatry, Stony Brook School of Medicine, Stony Brook
[2] Department of Psychiatry, Indiana University School of Medicine, Indianapolis
[3] Lilly Research Laboratories, Eli Lilly and Company, Indianapolis
关键词
Methylphenidate; ADHD Symptom; Study Phase; Atomoxetine; Stimulant Medication;
D O I
10.1186/1753-2000-1-10
中图分类号
学科分类号
摘要
Background: This study examined augmenting atomoxetine with extended-release methylphenidate in children whose attention-deficit/ hyperactivity disorder (ADHD) previously failed to respond adequately to stimulant medication. Methods: Children with ADHD and prior stimulant treatment (N = 25) received atomoxetine (1.2 mg/kg/day) plus placebo. After 4 weeks, patients who were responders (n = 4) were continued on atomoxetine/ placebo while remaining patients were randomly assigned to either methylphenidate (ATX/MPH) (1.1 mg/kg/day) or placebo augmentation (ATX/ PB) for another 6 weeks. Patients and sites were blind to timing of active augmentation. Safety measures included vital signs, weight, and adverse events. Efficacy was assessed by ADHD rating scales. Results: Categorical increases in vital signs occurred for 5 patients (3 patients in ATX/MPH, 2 patients in ATX/PBO). Sixteen percent discontinued the study due to AE, but no difference between augmentation groups. Atomoxetine treatment was efficacious on outcome measures (P ≤ .001), but methylphenidate did not enhance response. Conclusion: Methylphenidate appears to be safely combined with atomoxetine, but conclusions limited by small sample. With atomoxetine treatment, 43% of patients achieved normalization on ADHD ratings. © 2007 Carlson et al; licensee BioMed Central Ltd.
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