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Title: A multi-centre, randomised, double-blind, placebo-controlled clinical trial of methylphenidate in the initial treatment of acute mania (MEMAP study)
Author: Hegerl, Ulrich
Mergl, Roland
Sander, Christian
Dietzel, Jens
Bitter, Istvan
Demyttenaere, Koen
Gusmão, Ricardo
González Pinto, Ana
Zorrilla, Iñaki
García Alocén, Adriana
Pérez Sola, Victor
Vieta i Pascual, Eduard, 1963-
Juckel, Georg
Zimmermann, Ulrich S.
Bauer, Michael
Sienaert, Pascal
Quintão, Sónia
Edel, Marc-Andreas
Bolyos, Csilla
Ayuso Mateos, Jose Luis
López García, Pilar
Kluge, Michael
Keywords: Psicosi
Antipsychotic drugs
Placebos (Medicine)
Issue Date: Jan-2018
Publisher: Elsevier B.V.
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 (20-40 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.
Note: Versió postprint del document publicat a:
It is part of: European Neuropsychopharmacology, 2018, vol. 28, num. 1, p. 185-194
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ISSN: 0924-977X
Appears in Collections:Articles publicats en revistes (Institut de Recerca de la Biodiversitat (IRBio))
Articles publicats en revistes (Medicina)

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