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
AuthorKluge, Michael; Hegerl, Ulrich; Sander, Christian; Dietzel, Jens; Mergl, Roland; Bitter, István; Demyttenaere, Koen; Gusmão, Ricardo M.; González-Pinto, Ana María; Pérez-Solà, Victoŕ; Vieta, Eduard; Juckel, Georg; Zimmermann, Ulrich S.; Bauer, Michael S.; Sienaert, Pascal A.; Quintão, Sónia Dos Reis; Edel, Marc Andreas; Bolyos, Csilla; Ayuso Mateos, José Luis; López-García, Pilar
EntityUAM. Departamento de Psiquiatría
10.1186/1471-244X-13-71BMC Psychiatry 13 (2013): 71
Funded byThe study is supported by a grant of the Spanish ‘Ministerio de Sanidad, Politica Social e Igualdad’ (Ministry of Health, Social Politics and Equality) which was provided after a peer review process and by the Instituto de Salud Carlos III of Spain. Study drug is kindly provided by Medice, Iserlohn, Germany. Training videos for training on the YMRS are kindly provided by Bracket, Wayne, USA
SubjectsBipolar disorder; EEG; Mania; Methylphenidate; Psychostimulants; Vigilance; Medicina
Rights© 2013 Kluge et al; licensee BioMed Central Ltd.
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.
Google Scholar:Kluge, Michael - Hegerl, Ulrich - Sander, Christian - Dietzel, Jens - Mergl, Roland - Bitter, István - Demyttenaere, Koen - Gusmão, Ricardo M. - González-Pinto, Ana María - Pérez-Solà, Victoŕ - Vieta, Eduard - Juckel, Georg - Zimmermann, Ulrich S. - Bauer, Michael S. - Sienaert, Pascal A. - Quintão, Sónia Dos Reis - Edel, Marc Andreas - Bolyos, Csilla - Ayuso Mateos, José Luis - López-García, Pilar
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