Authors
Michael Kluge, Ulrich Hegerl, Christian Sander, Jens Dietzel, Roland Mergl, Istvan Bitter, Koen Demyttenaere, Ricardo Gusmão, Ana Gonzalez-Pinto, Victor Perez-Sola, Eduard Vieta, Georg Juckel, Ulrich S Zimmermann, Michael Bauer, Pascal Sienaert, Sónia Quintão, Marc-Andreas Edel, Csilla Bolyos, Jose Luis Ayuso-Mateos, Pilar López-García
Publication date
2013/12
Journal
BMC psychiatry
Volume
13
Pages
1-9
Publisher
BioMed Central
Description
Background
Treatment of patients with acute mania remains a considerable medical challenge since onset of action of antimanic medication is delayed for several days. Psychostimulants could have an earlier onset of action. This assumption is based on the ‘vigilance regulation model of mania’ which postulates that vigilance is unstable in manic patients. Accordingly, vigilance-stabilising psychostimulants could be more useful than conventional treatment in acute mania. We present here the study protocol of a trial intended to study the efficacy and safety of methylphenidate in the initial treatment of acute mania.
Methods/design
A multi-centre, randomised, double-blind, placebo-controlled clinical trial will be conducted in 88 bipolar inpatients with acute mania. Male and female patients older than 18 years will be randomised to treatment with either …
Scholar articles
M Kluge, U Hegerl, C Sander, J Dietzel, R Mergl, I Bitter… - BMC psychiatry, 2013