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. 2013 Feb 27;13:71. doi: 10.1186/1471-244X-13-71

Table 1.

Schedule of study assessments

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

*day -1 after informed consent.

Number of ‘X’ represents number of assessments (X* 15 mg methylphenidate vs. placebo, X** 20 mg methylphenidate vs. placebo).