Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: A 13-week, randomized, double-blind, placebo-controlled, fixed-dose study
Abstract
OBJECTIVES: Methylphenidate (MPH) is effective for adults with attention-deficit/hyperactivity disorder (ADHD). This study aimed to evaluate the efficacy and safety of OROS MPH in adults with ADHD. METHODS: Randomized, double-blind study; 279 subjects received OROS MPH 54 or 72 mg/day, or placebo, for 13 weeks. Primary endpoint was the Conners' Adult ADHD Rating Scale - Screening Version (CAARS-O:SV). Secondary outcomes included CAARS Self Report - Short Version (CAARS-S:S), Sheehan Disability Scale (SDS) and ADHD Impact Module - Adult (AIM-A). RESULTS: Improvements in CAARS-O:SV were significantly greater with OROS MPH 72 mg vs. placebo (P = 0.0024). CAARS-S:S scores decreased significantly vs. placebo in both OROS MPH arms (P < 0.05). There was no significant change in SDS score from baseline in either treatment arm, although significant benefit vs. placebo was observed on several AIM-A subscales. Treatment was well tolerated. CONCLUSIONS: OROS MPH provided overall benefits in the treatment of adults with ADHD.
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Several stimulants are effective in the treatment of adult ADHD.
“Similar to present review, several stimulants are effective in the treatment of adult ADHD.”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [33]
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Associations of sleep disturbance with ADHD: implications for treatment
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Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD
Maneeton, B., Maneeton, N., Suttajit, S., Reungyos, J., Srisurapanont, M., & Martin, S. (2014) · Drug Design, Development and Therapy · doi:10.2147/dddt.s68393 · Cited by 27 · see citing works
“For instance, recent evidence has shown the efficacy of the extended-release (ER) formulation of MPH 31 and osmotic-release oral system (OROS) MPH. 32,33 Previous studies have shown that the response rate of MPH ER treatment vs placebo (50% vs 18”
- Authors
- Casas, M., Rösler, M., Sandra Kooij, J. J., Ginsberg, Y., Ramos-Quiroga, J. A., Heger, S., Berwaerts, J., Dejonckheere, J., van der Vorst, E., & Schäuble, B.
- Affiliations
- Universitat Autònoma de Barcelona (ES)
- Universitätsklinikum des Saarlandes (DE)
- Psycho-Medical Programs, Program Adult ADHD
- Karolinska Institutet (SE)
- Department of Psychiatry, Hospital Universitari Vall d’Hebron, CIBERSAM, Department of Psychiatry and Legal Medicine, Universitat Autònoma de Barcelona
- Private Practice
- Johnson & Johnson Pharmaceutical Research & Development
- SGS Life Science Services
- Global Clinical Operations, Janssen EMEA
- Janssen (Germany) (DE)
- Corresponding author
- Casas, Miguel
- Venue
- The World Journal of Biological Psychiatry
- Publisher
- Informa UK Limited
- Published
- 2011-11-22
- Volume
- 14
- Issue
- 4
- Pages
- 268-281
- ISSN
- 1562-2975 (ISSN-L)
- 1814-1412
- OpenAlex
- W2074299827
- Cited by
- 38
- References
- 9
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 5 · 2023: 1 · 2022: 5 · 2021: 1 · 2020: 2 · 2018: 2 · 2017: 2 · 2016: 3 · 2015: 1 · 2014: 6 · 2013: 2 · 2012: 2
- FWCI
- 2.18
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The World Journal of Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Eli Lilly and Company
- Fundación Alicia Koplowitz
- Johnson and Johnson
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroethics, Human Enhancement, Biomedical Innovations
- Keywords
- methylphenidate, sustained-release formulation, OROS methylphenidate, adult ADHD, ADHD medication, treatment efficacy, drug safety, symptom severity, functioning impairment, quality of life, tolerability
- MeSH terms
- Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Methylphenidate, Middle Aged, Osmosis, Treatment Outcome, Young Adult
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