Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
6790982 | European Neuropsychopharmacology | 2018 | 10 Pages |
Abstract
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 (20-40Â mg/day). Of 157 screened patients with acute mania, 42 were randomly assigned to receive 20-40Â 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. Trial registration: clinicaltrials.gov (URL: http://www.clinicaltrials.gov; registration number: NCT01541605).
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Authors
Ulrich Hegerl, Roland Mergl, Christian Sander, Jens Dietzel, Istvan Bitter, Koen Demyttenaere, Ricardo Gusmão, Ana González-Pinto, Iñaki Zorrilla, Adriana GarcÃa Alocén, Victor Perez Sola, Eduard Vieta, Georg Juckel, Ulrich S. Zimmermann,