Cited by 186Attention Deficit Hyperactivity DisorderSchizophrenia research and treatmentPharmaceutical studies and practices

A Randomized, Placebo-Controlled Trial of Three Fixed Dosages of Prolonged-Release OROS Methylphenidate in Adults with Attention-Deficit/Hyperactivity Disorder

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Medori, Rossella, Ramos-Quiroga, J. Antoni, Casas, Miguel, Kooij, J.J.S., Niemelä, Asko, Trott, Götz-Erik, Lee, Emma, Buitelaar, Jan K.·2008·Biological Psychiatry

Abstract

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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  1. [6]6. U.S. Food and Drug Administration (2007): FDA Directs ADHD Drug Man- ufacturers to Notify Patients about Cardiovascular Adverse Events and Psychiatric Adverse Events. Rockville, MD: National Press Office. Press P07-26.
  2. [27]27. First M, Spitzer R, Gibbon M, Williams G (1994): Structured Clinical Inter- view for DSM-IV Axis I Disorders, Patient Edition (SCID-P), Version 2. New York: New York State Psychiatric Institute, Biometrics Research.

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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
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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