Open Access Study protocol

Methylphenidate in mania project (MEMAP): study protocol of an international randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate

Michael Kluge1, Ulrich Hegerl1*, Christian Sander1, Jens Dietzel1, Roland Mergl1, Istvan Bitter2, Koen Demyttenaere3, Ricardo Gusmão4, Ana Gonzalez-Pinto56, Victor Perez-Sola67, Eduard Vieta68, Georg Juckel9, Ulrich S Zimmermann10, Michael Bauer10, Pascal Sienaert3, Sónia Quintão4, Marc-Andreas Edel9, Csilla Bolyos2, Jose Luis Ayuso-Mateos11126 and Pilar López-García126

Author Affiliations

1 Department of Psychiatry and Psychotherapy, University of Leipzig, Semmelweisstrasse 10, 04103, Leipzig, Germany

2 Department of Psychiatry and Psychotherapy, Semmelweis University, Budapest, Hungary

3 Department of Psychiatry, University Psychiatric Center KU Leuven, Leuven, Belgium

4 CEDOC, Clínica Universitária de Psiquiatria e Saúde Mental, Faculdade de Ciências Médicas de Lisboa, Lisbon, Portugal

5 Department of Psychiatry, Hospital Santiago Apostol, Vitoria, Spain

6 Centro de Investigació n Biomé dica en Red de Salud Mental. CIBERSAM, Madrid, Spain

7 Department of Psychiatry, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

8 Department of Psychiatry, Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain

9 Department of Psychiatry and Psychotherapy, University of Bochum, Bochum, Germany

10 Department of Psychiatry and Psychotherapy, University Hospital Dresden, Dresden, Germany

11 Department of Psychiatry, Universidad Autonoma de Madrid, Madrid, Spain

12 Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain

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BMC Psychiatry 2013, 13:71  doi:10.1186/1471-244X-13-71

Published: 27 February 2013

Abstract

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 methylphenidate (20 to 40 mg/day) or placebo for 2.5 days, given once or twice daily. The main outcome measure is the reduction in the Young Mania Rating Scale (YMRS) after 2.5 days of treatment. Other outcome measures include the Positive and Negative Syndrome Scale-Excited Component (PANSS-EC) the Clinical Global Impression–Bipolar Scale (CGI-BP), the Screen for Cognitive Impairment in Psychiatry (SCIP), actigraphy and the EEG-‘Vigilance Algorithm Leipzig’ (VIGALL).

Discussion

A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.

Trial registration

ClinicalTrials.gov: NCT 01541605

Keywords:
Psychostimulants; Mania; Bipolar disorder; Methylphenidate; Vigilance; EEG