Efficacy and safety of methylphenidate in 45 adults with attention-deficit/hyperactivity disorder. A randomized placebo-controlled double-blind cross-over trial
Open accessAbstract
Background. Data on the efficacy and safety of methylphenidate in adults with attention deficit/hyperactivity disorder (ADHD) are lacking in Europe. This study was undertaken to report on the efficacy and safety of methylphenidate in an adult out-patient population with ADHD, and to compare results with US data. Method. A double-blind randomized cross-over trial comparing methylphenidate and placebo in 45 adults with ADHD with childhood onset was performed in a dose–titration design. Methylphenidate was titrated from 0·5 mg/kg per day in week 1 up to 1·0 mg/kg per day in week 3. Results. Response rates using methylphenidate varied between 38 and 51%, and using placebo between 7 and 18% ( p <0·05), depending on outcome measure used. Although the overall percentage of subjects having any side effect on both methylphenidate and placebo was rather high, side effects on methylphenidate over and above those on placebo were few and mild. Conclusions. Methylphenidate proves to be an effective and well tolerated treatment for symptoms of ADHD in adults in the short term. Future research should study the long-term response and clarify the impact of gender, co-morbidity, socio-economic status and IQ on response rates in adults with ADHD.
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In adults, comorbidity is the rule, with 75% of clinical patients having at least one other disorder, and mean number of psychiatric comorbidities being three.
“Similarly in adults, co-morbidity is the rule, with 75% of clinical patients having at least one other disorder, and the mean number of psychiatric comorbidities being three [41,148].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [148]
Comorbidity is the rule rather than the exception in adult ADHD.
“Comorbidity being the rule rather than the exception, the evaluation of co-occurring symptoms, syndromes and disorders must always be part of the clinical assessment of adult ADHD [148,150].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [148]
Side-effects of stimulants are usually mild and transitory, mainly consisting of headache, reduced appetite, palpitations, nervousness, difficulty falling asleep, and dry mouth.
“Side-effects are usually mild and transitory, mainly consisting of headache, reduced appetite, palpitations, nervousness, difficulty falling asleep, and dry mouth [148,269,270].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [148]
Compliance to frequent dosing regimens is poor in ADHD patients due to forgetfulness, inattentiveness and self-organisation problems, leading to daily instability by frequent rebound symptoms and ineffective treatment.
“Compliance to such frequent dosing regimens is however poor in ADHD patients due to forgetfulness, inattentiveness and self-organisation problems, leading to daily instability by frequent rebound symptoms and ineffective treatment [148,289-291].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [148]
Adults require repetitive dosing with immediate release stimulants, of between three to four doses in most cases, and more often in others, to avoid rebound symptoms and for adequate control of ADHD symptoms during the day and evening.
“The requirement for a longer duration of activity in adults, requires repetitive dosing with immediate release stimulants, of between three to four doses in most cases, and more often in others, to avoid rebound symptoms and for adequate control of ADHD symptoms during the day and evening [148,270].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [148]
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- Authors
- KOOIJ, J. J. S., BURGER, H., BOONSTRA, A. M., VAN DER LINDEN, P. D., KALMA, L. E., & BUITELAAR, J. K.
- Affiliations
- Radboud University Medical Center (NL)
- Venue
- Psychological Medicine
- Publisher
- Cambridge University Press (CUP)
- Published
- 2004-08
- Volume
- 34
- Issue
- 6
- Pages
- 973-982
- ISSN
- 0033-2917 (ISSN-L)
- 1469-8978
- OpenAlex
- W2093719531
- Cited by
- 163
- References
- 29
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 2 · 2022: 1 · 2021: 7 · 2020: 5 · 2019: 5 · 2018: 1 · 2017: 1 · 2016: 6 · 2015: 8 · 2014: 10 · 2013: 12 · 2012: 13
- FWCI
- 7.67
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Locations
- Psychological Medicine (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Digital Academic REpository of VU University Amsterdam (Vrije Universiteit Amsterdam) (submittedVersion)
- VU Research Portal (submittedVersion, other-oa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion, other-oa)
- Radboud Repository (Radboud University) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Hersenstichting
- Nationaal Fonds Geestelijke Volksgezondheid
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- methylphenidate, adult ADHD, ADHD medication, dose titration, treatment efficacy, drug safety, adverse effects, childhood-onset ADHD, outpatients
- MeSH terms
- Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Double-Blind Method, Female, Humans, Male, Methylphenidate, Middle Aged, Placebos, Treatment Outcome, Cross-Over Studies
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