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

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 m...

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Autores principales: Retz, Wolfgang, Rösler, Michael, Ose, Claudia, Scherag, André, Alm, Barbara, Philipsen, Alexandra, Fischer, Roland, Ammer, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Informa Healthcare 2012
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279134/
https://www.ncbi.nlm.nih.gov/pubmed/21155632
http://dx.doi.org/10.3109/15622975.2010.540257
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author Retz, Wolfgang
Rösler, Michael
Ose, Claudia
Scherag, André
Alm, Barbara
Philipsen, Alexandra
Fischer, Roland
Ammer, Richard
author_facet Retz, Wolfgang
Rösler, Michael
Ose, Claudia
Scherag, André
Alm, Barbara
Philipsen, Alexandra
Fischer, Roland
Ammer, Richard
author_sort Retz, Wolfgang
collection PubMed
description 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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spelling pubmed-32791342012-02-28 Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate Retz, Wolfgang Rösler, Michael Ose, Claudia Scherag, André Alm, Barbara Philipsen, Alexandra Fischer, Roland Ammer, Richard World J Biol Psychiatry Original Investigation 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. Informa Healthcare 2012-01 2010-12-14 /pmc/articles/PMC3279134/ /pubmed/21155632 http://dx.doi.org/10.3109/15622975.2010.540257 Text en © 2012 Informa Healthcare http://creativecommons.org/licenses/by/2.0/ This is an open access article distributed under the Supplemental Terms and Conditions for iOpenAccess articles published in Informa Healthcare journals (http://www.informaworld.com/mpp/uploads/iopenaccess_tcs.pdf) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Investigation
Retz, Wolfgang
Rösler, Michael
Ose, Claudia
Scherag, André
Alm, Barbara
Philipsen, Alexandra
Fischer, Roland
Ammer, Richard
Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title_full Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title_fullStr Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title_full_unstemmed Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title_short Multiscale assessment of treatment efficacy in adults with ADHD: A randomized placebo-controlled, multi-centre study with extended-release methylphenidate
title_sort multiscale assessment of treatment efficacy in adults with adhd: a randomized placebo-controlled, multi-centre study with extended-release methylphenidate
topic Original Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3279134/
https://www.ncbi.nlm.nih.gov/pubmed/21155632
http://dx.doi.org/10.3109/15622975.2010.540257
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