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. 2007 Sep 27;1(1):10.
doi: 10.1186/1753-2000-1-10.

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

Gabrielle A Carlson  1 , David Dunn, Douglas Kelsey, Dustin Ruff, Susan Ball, Lisa Ahrbecker, Albert J Allen
Affiliations

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

Gabrielle A Carlson et al. Child Adolesc Psychiatry Ment Health. .

Abstract

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 <or= .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.

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Figures

Figure 1
Figure 1
ADHDRS-IV-Parent:Inv mean total scores (SE) across treatment weeks. *P ≤ .05, atomoxetine and placebo (excluding early responders) vs atomoxetine and methylphenidate.
See this image and copyright information in PMC

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