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
Kluge, Michael (University of Leipzig (Alemanya))
Hegerl, Ulrich (University of Leipzig (Alemanya))
Sander, Christian (University of Leipzig (Alemanya))
Dietzel, Jens (University of Leipzig (Alemanya))
Mergl, Roland (University of Leipzig (Alemanya))
Bitter, István (Semmelweis University (Budapest, Hongria))
Demyttenaere, Koen (University Psychiatric Center KU Leuven (Leuven, Bèlgica))
Gusmão, R. (Clínica Universitária de Psiquiatria e Saúde Mental (Portugal))
Gonzalez-Pinto, Ana María (Centro de Investigación Biomédica en Red de Salud Mental)
Pérez Solà, Víctor (Institut d'Investigació Biomèdica Sant Pau)
Vieta, Eduard (Universitat de Barcelona)
Juckel, Georg (University of Bochum (Alemanya))
Zimmermann, Ulrich S. (University Hospital Dresden (Alemanya))
Bauer, Michael (University Hospital Dresden (Alemanya))
Sienaert, Pascal A. (University Psychiatric Center KU Leuven (Leuven, Bèlgica))
Quintão, Sónia Dos Reis (Clínica Universitária de Psiquiatria e Saúde Mental (Lisboa, Portugal))
Edel, Marc Andreas (University of Bochum (Alemanya))
Bolyos, Csilla (Semmelweis University (Budapest, Hongria))
Ayuso-Mateos, Jose Luis (Instituto de Investigación Sanitaria Princesa (Madrid))
López-García, Pilar (Instituto de Investigación Sanitaria Princesa (Madrid))
Universitat Autònoma de Barcelona

Data:	2013
Resum:	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. © 2013 Kluge et al; licensee BioMed Central Ltd.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Bipolar disorder ; EEG ; Mania ; Methylphenidate ; Psychostimulants ; Vigilance
Publicat a:	BMC Psychiatry, Vol. 13 (27 2013) , p. 71, ISSN 1471-244X

DOI: 10.1186/1471-244X-13-71
PMID: 23446109

9 p, 344.4 KB

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