Atomoxetine and Osmotically Released Methylphenidate for the Treatment of Attention Deficit Hyperactivity Disorder: Acute Comparison and Differential Response
Abstract
OBJECTIVE: Response to atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD). METHOD: In a large placebo-controlled, double-blind study, patients ages 6-16 with ADHD, any subtype, were randomly assigned to receive 0.8-1.8 mg/kg per day of atomoxetine (N=222), 18-54 mg/day of osmotically released methylphenidate (N=220), or placebo (N=74) for 6 weeks. The a priori specified primary analysis compared response (at least 40% decrease in ADHD Rating Scale total score) to osmotically released methylphenidate with response to atomoxetine and placebo. After 6 weeks, patients treated with methylphenidate were switched to atomoxetine under double-blind conditions. RESULTS: The response rates for both atomoxetine (45%) and methylphenidate (56%) were markedly superior to that for placebo (24%), but the response to osmotically released methylphenidate was superior to that for atomoxetine. Each medication was well tolerated, with completion rates and discontinuations for adverse events not significantly different from those for placebo. Of the 70 subjects who did not respond to methylphenidate, 30 (43%) subsequently responded to atomoxetine. Likewise, 29 (42%) of the 69 patients who did not respond to atomoxetine had previously responded to osmotically released methylphenidate. CONCLUSION: Response was significantly greater with osmotically released methylphenidate than with atomoxetine. One-third of patients who received methylphenidate followed by atomoxetine responded better to one or the other, suggesting that there may be preferential responders.
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Stimulant medications have an effect size of around 1.0 for the treatment of ADHD.
“Stimulant medications have an effect size of around 1.0 (effect size = [treatment M − control M)/control SD]) for the treatment of ADHD.98”
From Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents (2019) · cites this paper as [98]
The shared and distinct substrates of stimulant and nonstimulant effects may delineate a novel therapeutic target for effective interventions and could account for different therapeutic responses to stimulants and nonstimulants among individuals with ADHD.
“These shared and distinct substrates may delineate a novel therapeutic target for effective interventions and could account for different therapeutic responses to stimulants and nonstimulants among individuals with ADHD”
From Overlapping and differential neuropharmacological mechanisms of stimulants and nonstimulants for attention-deficit/hyperactivity disorder: A comparative neuroimaging analysis (2024) · cites this paper as Newcorn et al., 2008
Approximately 56% of ADHD cases may achieve clinical improvement with stimulants, while 45% of cases achieve so with non-stimulants.
“approximately 56% of ADHD cases may achieve clinical improvement with stimulants, while 45% of cases achieve so with non-stimulants (Mechler et al., 2022; Newcorn et al., 2008).”
From Overlapping and differential neuropharmacological mechanisms of stimulants and nonstimulants for attention-deficit/hyperactivity disorder: A comparative neuroimaging analysis (2024) · cites this paper as Newcorn et al., 2008
Lower frequencies of insomnia and higher frequencies of somnolence with atomoxetine than with long-acting stimulants have been reported as TEAEs in randomized, double-blind, parallel-group efficacy studies.
“Lower frequencies of insomnia and higher frequencies of somnolence with atomoxetine than with long-acting stimulants have been reported as TEAEs in randomized, double-blind, parallel-group efficacy studies (Dittmann et al. 2013; Newcorn et al. 2008).”
From Associations of sleep disturbance with ADHD: implications for treatment (2015) · cites this paper as Newcorn et al. 2008
One large (n = 516), double-blind, placebo-controlled, crossover study found that the proportions of stimulant-naïve children with ADHD who responded to OROS-MPH and ATX (64 and 57%, effect sizes 1.0 and 0.9) were higher than among those who had previously been treated with a psychostimulant (51 and 37%, effect sizes 0.8 and 0.5).
“In contrast, one large (n = 516), double-blind, placebo-controlled, crossover study found that the proportions of stimulant-naïve children with ADHD who responded to osmotic-release oral system MPH (OROS-MPH) and ATX (64 and 57 %, respectively; effect sizes relative to placebo based on ADHD-RS-IV total score, 1.0 and 0.9) were higher than among those who had previously been treated with a psychost”
Nine randomized trials comparing methylphenidate and atomoxetine in ADHD children and adolescents were included, with a total of 2762 participants.
“Nine randomized trials comparing methylphenidate and atomoxetine, with a total of 2762 participants were included.”
Two trials excluded participants with previous poor response to methylphenidate, a design feature that would have favoured methylphenidate.
“Two trials excluded participants with previous poor response to methylphenidate, a design feature which would have favoured methylphenidate [27,28].”
Higher doses of atomoxetine administered twice daily may be more effective.
“The outcome in three of these trials favoured atomoxetine suggesting that higher doses of atomoxetine administered twice daily may be more effective.”
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- Authors
- Newcorn, J. H., Kratochvil, C. J., Allen, A. J., Casat, C. D., Ruff, D. D., Moore, R. J., Michelson, D., & Atomoxetine/Methylphenidate Comparative Study Group
- Affiliations
- Mount Sinai Hospital (US)
- Venue
- American Journal of Psychiatry
- Published
- 2008-06
- Volume
- 165
- Issue
- 6
- Pages
- 721-730
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- OpenAlex
- W2130386846
- Cited by
- 336
- References
- 23
- Citations by year
- 2026: 3 · 2025: 10 · 2024: 10 · 2023: 11 · 2022: 8 · 2021: 10 · 2020: 9 · 2019: 14 · 2018: 9 · 2017: 21 · 2016: 20 · 2015: 33 · 2014: 32 · 2013: 20 · 2012: 30
- FWCI
- 22.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Social Sciences › Psychology › Developmental and Educational Psychology › Behavioral and Psychological Studies
- Keywords
- atomoxetine, attention deficit hyperactivity disorder, non-stimulant medication, norepinephrine reuptake inhibitors, treatment response, differential drug response, children and adolescents, ADHD Rating Scale
- MeSH terms
- Atomoxetine Hydrochloride, Adolescent, Central Nervous System Stimulants, Child, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Personality Assessment, Propylamines, Treatment Outcome, Cross-Over Studies, Adrenergic Uptake Inhibitors
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