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Table 1 Schedule of study assessments

From: 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

Examination/evaluation Screening Treatment Follow up
Day -2/-1 0 1 2 3 9
  Review Inclusion/Exclusion criteria X      
  Informed consent X      
  Randomisation *X (X)     
General       
  Medical and psychiatric history X      
  Demographics and illness characteristics X      
  Physical examination X      
  Vital signs X X X X X X
  Blood analysis X     X X
  Urine analysis, drug screening X      X
  Pregnancy test *X      
  Concomitant medication X X X X   X
  Baseline findings/adverse events X X X X   X
  ECG X    X   X
  ADHD-Screening      X  
Efficacy       
  YMRS X XX X X X X
  CGI-BP   X   X X X
  PANSS-EC   XXXXX X X X X
  EEG   X   X   
  Actigraphy *X X X X   
  Cognitive test   X X X   
Medication       
  Study drug: methylphenidate, placebo   X*X* X**X** X**   
  Up to 3 mg/day lorazepam or alprazolam X      
  Up to 2 mood-stabilisers allowed X X X X X X
  1. *day -1 after informed consent.
  2. Number of ‘X’ represents number of assessments (X* 15 mg methylphenidate vs. placebo, X** 20 mg methylphenidate vs. placebo).