A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study)
Based on many clinical and preclinical findings the 'vigilance regulation model of mania' postulates that an unstable regulation of wakefulness is a pathogenetic factor in both mania and Attention Deficit Hyperactivity Disorder (ADHD) and induces hyperactivity and sensation seeking as an autoregulat...
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| Format: | Article |
| Status: | Accepted version |
| Publication date: | 2018 |
| Country: | España |
| Institution: | Universidad de Barcelona |
| Repository: | Dipòsit Digital de la UB |
| OAI Identifier: | oai:diposit.ub.edu:2445/131382 |
| Online Access: | https://hdl.handle.net/2445/131382 |
| Access Level: | Open access |
| Keyword: | Psicosi Antipsicòtics Placebos Psychoses Antipsychotic drugs Placebos (Medicine) |
| _version_ | 1878738305602813952 |
|---|---|
| author | Hegerl, Ulrich |
| author2 | Mergl, Roland Sander, Christian Dietzel, Jens Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Zorrilla, Iñaki García Alocén, Adriana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintão, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar Kluge, Michael |
| author2_role | author author author author author author author author author author author author author author author author author author author author author |
| author_browse | Ayuso Mateos, José Luis Bauer, Michael Bitter, Istvan Bolyos, Csilla Demyttenaere, Koen Dietzel, Jens Edel, Marc-Andreas García Alocén, Adriana González-Pinto, Ana Gusmão, Ricardo Hegerl, Ulrich Juckel, Georg Kluge, Michael López García, Pilar Mergl, Roland Pérez Solà, Victor Quintão, Sónia Sander, Christian Sienaert, Pascal Vieta i Pascual, Eduard, 1963- Zimmermann, Ulrich S. Zorrilla, Iñaki |
| author_facet | Hegerl, Ulrich Mergl, Roland Sander, Christian Dietzel, Jens Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Zorrilla, Iñaki García Alocén, Adriana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintão, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar Kluge, Michael |
| author_role | author |
| collection | Dipòsit Digital de la UB |
| description | Based on many clinical and preclinical findings the 'vigilance regulation model of mania' postulates that an unstable regulation of wakefulness is a pathogenetic factor in both mania and Attention Deficit Hyperactivity Disorder (ADHD) and induces hyperactivity and sensation seeking as an autoregulatory attempt to stabilize wakefulness. Accordingly, stimulant medications with their vigilance stabilizing properties could have rapid antimanic effects similar to their beneficial effects in ADHD. The MEMAP study - a multi-center, double-blind, placebo-controlled and randomized clinical trial (RCT) - assessed the antimanic efficacy and safety of a 2.5-day treatment with methylphenidate (20-40 mg/day). Of 157 screened patients with acute mania, 42 were randomly assigned to receive 20-40 mg per day of methylphenidate in one or two applications, or placebo. The primary outcome was the change in Young Mania Rating Scale (YMRS) sum scores from baseline to day 2.5 in the methylphenidate group compared to the placebo group. A group sequential design was chosen to justify early RCT termination based on efficacy or futility at an interim analysis after inclusion of 40 patients. In the interim analysis, the change from baseline in the YMRS total score at day 2.5 was not significantly different between both groups (F(1,37)=0.23; p=0.64). Thus, futility was declared for methylphenidate and the RCT was stopped. In summary, although methylphenidate was well tolerated and safe in the full analysis set, it failed to show efficacy in the treatment of acute mania. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_acd73bcff486862f85be5526367f3476 |
| institution | Universidad de Barcelona |
| instname_str | Universidad de Barcelona |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:diposit.ub.edu:2445/131382 |
| publishDate | 2018 |
| publishDateSort | 2018 |
| publisher | Elsevier B.V. |
| publisherStr | Elsevier B.V. |
| reponame_str | Dipòsit Digital de la UB |
| spelling | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) Hegerl, Ulrich Mergl, Roland Sander, Christian Dietzel, Jens Bitter, Istvan Demyttenaere, Koen Gusmão, Ricardo González-Pinto, Ana Zorrilla, Iñaki García Alocén, Adriana Pérez Solà, Victor Vieta i Pascual, Eduard, 1963- Juckel, Georg Zimmermann, Ulrich S. Bauer, Michael Sienaert, Pascal Quintão, Sónia Edel, Marc-Andreas Bolyos, Csilla Ayuso Mateos, José Luis López García, Pilar Kluge, Michael Psicosi Antipsicòtics Placebos Psychoses Antipsychotic drugs Placebos (Medicine) Based on many clinical and preclinical findings the 'vigilance regulation model of mania' postulates that an unstable regulation of wakefulness is a pathogenetic factor in both mania and Attention Deficit Hyperactivity Disorder (ADHD) and induces hyperactivity and sensation seeking as an autoregulatory attempt to stabilize wakefulness. Accordingly, stimulant medications with their vigilance stabilizing properties could have rapid antimanic effects similar to their beneficial effects in ADHD. The MEMAP study - a multi-center, double-blind, placebo-controlled and randomized clinical trial (RCT) - assessed the antimanic efficacy and safety of a 2.5-day treatment with methylphenidate (20-40 mg/day). Of 157 screened patients with acute mania, 42 were randomly assigned to receive 20-40 mg per day of methylphenidate in one or two applications, or placebo. The primary outcome was the change in Young Mania Rating Scale (YMRS) sum scores from baseline to day 2.5 in the methylphenidate group compared to the placebo group. A group sequential design was chosen to justify early RCT termination based on efficacy or futility at an interim analysis after inclusion of 40 patients. In the interim analysis, the change from baseline in the YMRS total score at day 2.5 was not significantly different between both groups (F(1,37)=0.23; p=0.64). Thus, futility was declared for methylphenidate and the RCT was stopped. In summary, although methylphenidate was well tolerated and safe in the full analysis set, it failed to show efficacy in the treatment of acute mania. Elsevier B.V. https://hdl.handle.net/2445/131382 |
| spellingShingle | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) Hegerl, Ulrich Psicosi Antipsicòtics Placebos Psychoses Antipsychotic drugs Placebos (Medicine) |
| status_str | acceptedVersion |
| title | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| title_full | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| title_fullStr | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| title_full_unstemmed | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| title_short | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| title_sort | A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study) |
| topic | Psicosi Antipsicòtics Placebos Psychoses Antipsychotic drugs Placebos (Medicine) |
| topic_facet | Psicosi Antipsicòtics Placebos Psychoses Antipsychotic drugs Placebos (Medicine) |
| url | https://hdl.handle.net/2445/131382 |