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
Por:
Kluge, M, Hegerl, U, Sander, C, Dietzel, J, Mergl, R, Bitter, I, Demyttenaere, K, Gusmao, R, Gonzalez-Pinto, A, Perez-Sola, V, Vieta, E, Juckel, G, Zimmermann, US, Bauer, M, Sienaert, P, Quintao, S, Edel, MA, Bolyos, C, Ayuso-Mateos, JL, Lopez-Garcia, P
Publicada:
27 feb 2013
Resumen:
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.
Filiaciones:
Kluge, M:
Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
Hegerl, U:
Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
Sander, C:
Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
Dietzel, J:
Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
Mergl, R:
Univ Leipzig, Dept Psychiat & Psychotherapy, D-04103 Leipzig, Germany
Bitter, I:
Semmelweis Univ, Dept Psychiat & Psychotherapy, H-1085 Budapest, Hungary
Demyttenaere, K:
Univ Psychiat Ctr KU Leuven, Dept Psychiat, Louvain, Belgium
Gusmao, R:
CEDOC, Clin Univ Psiquiatria & Saude Mental, Fac Ciencias Med Lisboa, Lisbon, Portugal
Gonzalez-Pinto, A:
Hosp Santiago Apostol, Dept Psychiat, Vitoria, Spain
Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
Perez-Sola, V:
Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
Hosp Santa Creu & Sant Pau, Dept Psychiat, Barcelona, Spain
Vieta, E:
Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
Univ Barcelona, Dept Psychiat, IDIBAPS, Hosp Clin Barcelona, Barcelona, Spain
Juckel, G:
Ruhr Univ Bochum, Dept Psychiat & Psychotherapy, Bochum, Germany
Zimmermann, US:
Univ Hosp Dresden, Dept Psychiat & Psychotherapy, Dresden, Germany
Bauer, M:
Univ Hosp Dresden, Dept Psychiat & Psychotherapy, Dresden, Germany
Sienaert, P:
Univ Psychiat Ctr KU Leuven, Dept Psychiat, Louvain, Belgium
Quintao, S:
CEDOC, Clin Univ Psiquiatria & Saude Mental, Fac Ciencias Med Lisboa, Lisbon, Portugal
Edel, MA:
Ruhr Univ Bochum, Dept Psychiat & Psychotherapy, Bochum, Germany
Bolyos, C:
Semmelweis Univ, Dept Psychiat & Psychotherapy, H-1085 Budapest, Hungary
Ayuso-Mateos, JL:
Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
Univ Autonoma Madrid, Dept Psychiat, Madrid, Spain
Inst Invest Sanitaria Princesa IP, Madrid, Spain
Lopez-Garcia, P:
Ctr Invest Biomed Red Salud Mental CIBERSAM, Madrid, Spain
Inst Invest Sanitaria Princesa IP, Madrid, Spain
Gold, Green Published
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