Cited by 267Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentPharmaceutical studies and practices

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A Randomized, Placebo-Controlled Trial of OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder

Biederman, Joseph, Mick, Eric, Surman, Craig, Doyle, Robert, Hammerness, Paul, Harpold, Theresa, Dunkel, Stephanie, Dougherty, Meghan, Aleardi, Megan, Spencer, Thomas·2006·Biological Psychiatry

DOI 10.1016/j.biopsych.2005.09.011

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Abstract

Background The objective of this study was to evaluate the safety and efficacy of once-daily OROS methylphenidate (MPH) in the treatment of adults with DSM-IV attention-deficit/hyperactivity disorder (ADHD). Methods We conducted a randomized, 6-week, placebo-controlled, parallel-design study of OROS MPH in 141 adult subjects with DSM-IV ADHD, using standardized instruments for diagnosis. OROS MPH or placebo was initiated at 36 mg/day and titrated to optimal response, depending on efficacy and tolerability, up to 1.3 mg/kg/day. Results Treatment with OROS MPH was associated with clinically and statistically significant reductions in DSM-IV symptoms of inattention and hyperactivity/impulsivity relative to subjects treated with placebo. At endpoint, 66% of subjects (n = 44) receiving OROS MPH and 39% of subjects (n = 29) [corrected] receiving placebo attained our a priori definition of response of much or very much improved on the Clinical Global Impression-Improvement scale plus a >30% reduction in Adult ADHD Investigator System Report Scale score. OROS MPH was associated with small but statistically significant increases in systolic blood pressure (3.5 +/- 11.8 mm Hg), diastolic blood pressure (4.0 +/- 8.5 mm Hg), and heart rate (4.5 +/- 10.5 bpm). Conclusions These results show that treatment with OROS MPH in daily doses of up to 1.3 mg/kg/day was effective in the treatment of adults with ADHD. Because of the potential for increases in blood pressure and heart rate, subjects receiving treatment with MPH should be monitored for changes in blood pressure parameters during treatment.

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Authors: Biederman, J., Mick, E., Surman, C., Doyle, R., Hammerness, P., Harpold, T., Dunkel, S., Dougherty, M., Aleardi, M., & Spencer, T.
Affiliations: Harvard University (US)
Corresponding author: Biederman, Joseph
ORCID: Biederman, Joseph
Mick, Eric
Surman, Craig
Hammerness, Paul
Spencer, Thomas
Venue: Biological Psychiatry
Publisher: Elsevier BV
Published: 2006-05
Volume: 59
Issue: 9
Pages: 829-835
ISSN: 0006-3223 (ISSN-L)
DOI: 10.1016/j.biopsych.2005.09.011
OpenAlex: W2164676183
Cited by: 267
References: 29
Citations by year: 2026: 4 · 2025: 9 · 2024: 6 · 2023: 8 · 2022: 10 · 2021: 2 · 2020: 9 · 2019: 4 · 2018: 7 · 2017: 5 · 2016: 14 · 2015: 7 · 2014: 18 · 2013: 16 · 2012: 20
FWCI: 11.15
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: Biological Psychiatry (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: OROS methylphenidate, attention deficit hyperactivity disorder, adult ADHD, sustained-release formulation, inattention, hyperactivity/impulsivity, blood pressure, heart rate, drug safety and efficacy, dose titration
MeSH terms: Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Cardiovascular System, Dose-Response Relationship, Drug, Double-Blind Method, Drug Evaluation, Female, Follow-Up Studies, Humans, Male, Methylphenidate, Middle Aged, Psychiatric Status Rating Scales, Chi-Square Distribution, Treatment Outcome

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A Randomized, Placebo-Controlled Trial of OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder

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