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Cited by 79Attention Deficit Hyperactivity DisorderSchizophrenia research and treatmentPharmaceutical studies and practices

Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate

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Retz, Wolfgang, Rösler, Michael, Ose, Claudia, Scherag, André, Alm, Barbara, Philipsen, Alexandra, Fischer, Roland, Ammer, Richard +1 more·2012·The World Journal of Biological Psychiatry
DOI 10.3109/15622975.2010.540257PMC PMC3279134
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Abstract

OBJECTIVES: This trial was performed to test the efficacy and safety of an extended-release formulation of methylphenidate (MPH ER). METHODS: A total of 162 adults with ADHD according to DSM-IV were treated for 8 weeks with either two daily individually body weight-adjusted doses of MPH ER up to 1 mg/kg per day (N = 84) or placebo (N = 78). The primary efficacy outcome was the Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) 8 weeks after randomization. Secondary efficacy measures were the ADHD Diagnostic Checklist (ADHD-DC), the Conners Adult Attention Deficit Disorder Scale (CAARS-S:L), the Clinical Global Impression (CGI) and the Sheehan Disability Scale (SDS). RESULTS: At week 8 a significantly higher decline of the total WRAADDS score was found in the MPH ER group as compared to the placebo group (P = 0.0003). The rates of responders were 50% in the MPH ER and 18% in the placebo group (P < 0.0001). Furthermore, similar effects were observed for the secondary efficacy variable: ADHD-DC score (P = 0.004), CAARS-S:L score (P = 0.008) and the SDS score (P = 0.017). 50% of the MPH ER group and 24.4% of the placebo group were improved "much" or "very much" according to the CGI rating (P = 0.0001). MPH ER treatment was well tolerated. At week 2 also the mean heart rate was significantly higher in the MPH ER group as compared to the placebo group (P = 0.01). No differences between the study groups were observed regarding mean blood pressure at any visit. CONCLUSIONS: This clinical trial demonstrated statistically significant and clinical relevant effects of MPH ER in adults with ADHD for several self- and investigator-rated ADHD psychopathology and also functional efficacy measures.

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  • The response rate of MPH ER versus placebo (50% vs 18%) and OROS MPH versus placebo (67% vs 37%) in adult ADHD is comparable with the response rate in this review (lisdexamfetamine 70% vs placebo 37%).

    “Previous studies have shown that the response rate of MPH ER treatment vs placebo (50% vs 18%)31 and of OROS MPH treatment vs placebo (67% vs 37%)32 in adult ADHD is comparable with the response rate in this review (LDX [70%] vs placebo [37%]).”

    From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [31]

  • 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 [31]

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Authors
Retz, W., Rösler, M., Ose, C., Scherag, A., Alm, B., Philipsen, A., Fischer, R., Ammer, R., & The Study Group
Affiliations
  • Universitätsklinikum des Saarlandes (DE)
  • Institut für Medizinische Informatik, Biometrie und Epidemiologie (DE)
  • Central Institute of Mental Health (DE)
  • University of Freiburg (DE)
  • Medice (Germany) (DE)
Corresponding author
Retz, Wolfgang
ORCID
Venue
The World Journal of Biological Psychiatry
Publisher
Informa UK Limited
Published
2010-12-14
Volume
13
Issue
1
Pages
48-59
ISSN
  • 1562-2975 (ISSN-L)
  • 1814-1412
DOI
10.3109/15622975.2010.540257
PMC
PMC3279134
OpenAlex
W2168192650
Cited by
79
References
9
Citations by year
2026: 2 · 2025: 4 · 2024: 4 · 2023: 5 · 2022: 7 · 2021: 5 · 2020: 7 · 2018: 6 · 2017: 6 · 2016: 4 · 2015: 3 · 2014: 9 · 2013: 5 · 2012: 9
FWCI
3.72
Type
journal article
Language
en
Open access
Locations
  • The World Journal of Biological Psychiatry (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
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, extended-release methylphenidate, Sheehan Disability Scale, heart rate, blood pressure, treatment safety, functional disability
MeSH terms
Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Blood Pressure, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Female, Germany, Heart Rate, Humans, Male, Methylphenidate, Middle Aged, Psychiatric Status Rating Scales, Treatment Outcome, Young Adult

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