title: 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.
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
  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).
  
  
  CONCLUSIONS
  A positive study outcome of the proposed study could substantially impact our understanding of the etiopathogenesis of mania and open new treatment perspectives.
authors: Department of Psychiatry and Psychotherapy, University of Leipzig, Semmelweisstrasse 10, 04103, Leipzig, Germany.
authors: Michael
authors: M
authors: Kluge
authors: Ulrich
authors: U
authors: Hegerl
authors: Christian
authors: C
authors: Sander
authors: Jens
authors: J
authors: Dietzel
authors: Roland
authors: R
authors: Mergl
authors: Istvan
authors: I
authors: Bitter
authors: Koen
authors: K
authors: Demyttenaere
authors: Ricardo
authors: R
authors: Gusmão
authors: Ana
authors: A
authors: Gonzalez-Pinto
authors: Victor
authors: V
authors: Perez-Sola
authors: Eduard
authors: E
authors: Vieta
authors: Georg
authors: G
authors: Juckel
authors: Ulrich S
authors: US
authors: Zimmermann
authors: Michael
authors: M
authors: Bauer
authors: Pascal
authors: P
authors: Sienaert
authors: Sónia
authors: S
authors: Quintão
authors: Marc-Andreas
authors: MA
authors: Edel
authors: Csilla
authors: C
authors: Bolyos
authors: Jose Luis
authors: JL
authors: Ayuso-Mateos
authors: Pilar
authors: P
authors: López-García
mesh_terms: D000208:Acute Disease; D000328:Adult; D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D018692:Antimanic Agents; D008774:Methylphenidate