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A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder
Open accessAbstract
Background There is increasing recognition of attention-deficit/hyperactivity disorder (ADHD) in adults and the need to evaluate efficacy and safety of methylphenidate treatment in these patients.Methods In this double-blind trial, 401 adults with ADHD (218 men; 18-63 years) were randomly assigned to receive prolonged-release osmotic release oral system (OROS) methylphenidate (18 mg, 36 mg, or 72 mg/day) or placebo for 5 weeks. Primary outcome was change in total score on Conners' Adult ADHD Rating Scale (CAARS: investigator-rated) at end point compared with baseline. Adverse events, vital signs, and laboratory parameters were assessed.Results Treatment with 18-mg, 36-mg, and 72-mg/day prolonged-release methylphenidate, compared with placebo, was associated with significantly larger improvement in CAARS total symptom score from baseline to end point than placebo: mean change -10.6 (p = .01), -11.5 (p = .01), and -13.7 (p < .001) versus -7.6, respectively. Responders (> or = 30% decrease) were 50.5%, 48.5%, and 59.6% versus 27.4% (p < .001). Other efficacy measures also showed improvements. Incidence of adverse events was 75%, 76%, and 82% in 18-mg, 36-mg, and 72-mg/day groups, respectively, and 66% in placebo; most frequent included decreased appetite (25% methylphenidate; 7% placebo) and headache (21% methylphenidate; 18% placebo). In methylphenidate-treated patients, 4.3% discontinued due to adverse event; one serious adverse event was possibly related to study drug. Blood pressure and pulse increased at week 1 and then remained stable through week 5.Conclusions Prolonged-release methylphenidate is an effective treatment of ADHD in adults, with a safety profile consistent with methylphenidate use in pediatrics.
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Metadata
- Authors
- Medori, R., Ramos-Quiroga, J. A., Casas, M., Kooij, J. J. S., Niemelä, A., Trott, G.-E., Lee, E., & Buitelaar, J. K.
- Affiliations
- Janssen (Germany) (DE)
- Universitat Autònoma de Barcelona (ES)
- Oulu University Hospital (FI)
- Janssen (Belgium) (BE)
- Radboud University Medical Center (NL)
- Corresponding author
- Medori, Rossella
- Venue
- Biological Psychiatry
- Publisher
- Elsevier BV
- Published
- 2008-05
- Volume
- 63
- Issue
- 10
- Pages
- 981-989
- ISSN
- 0006-3223 (ISSN-L)
- OpenAlex
- W2167875798
- Cited by
- 186
- References
- 28
- Citations by year
- 2025: 3 · 2024: 5 · 2023: 6 · 2022: 9 · 2021: 3 · 2020: 6 · 2019: 6 · 2018: 4 · 2017: 7 · 2016: 6 · 2015: 4 · 2014: 17 · 2013: 13 · 2012: 19
- FWCI
- 18.15
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Locations
- Biological Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Radboud Repository (Radboud University) (submittedVersion)
- Funders
- Eli Lilly and Company
- Cilag
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- adult ADHD, osmotic-release oral system, fixed-dose comparison, treatment efficacy, adverse events, appetite loss, blood pressure, Conners' Adult ADHD Rating Scale, dose-response relationship
- MeSH terms
- Administration, Oral, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Methylphenidate, Middle Aged, Psychiatric Status Rating Scales, Severity of Illness Index, Infusion Pumps, Implantable, Treatment Outcome
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