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Table 4 Variable overview

From: The study protocol of the Norwegian randomized controlled trial of electroconvulsive therapy in treatment resistant depression in bipolar disorder

  Study visit 1 2 3 4 5 6 7 8 9 10 Comment
  Week -5t1/2 0 1 2 3 4 5 6 26 30-52 1) 1) in euthymic phase
  Test  
  Informed consent X           
Diagnostic interview SCID or MINI plus X           
  Inclusion/exclusion criteria X           
NORBRAIN Entry Questionnaire NEQ Socio demography Medical history etc X           
  PANSS X           
  GAF X        X X X  
  Clinical examination X           
  Current and concomitant medication X X X X X X X X X X  
Health related Quality of Life SF 36 X        X X X  
Efficacy MADRS X X2) X X X X X X2) X X 2) audio taped
  IDS X X2) X X X X X X2) X X 2) audio taped
  CGI-BP X X X X X X X X X X  
  PGI-I    X X X X X X X X  
  YMRS X X X X X X X X X X  
  MSIF X         X X  
Relapse Interview          X X  
Overall cognitive function MMS 3)   X X X X X X X    3) in ECT-group only
Neuropsychological assessment   X        X X X  
  EMQ X        X X X  
Adverse events Interview UKU   X4)    X    X    4) previous med.
  SAE-form    X X X X X X    
Lab Cytokines X        X X X  
  Cortisol 5)         X    5) morning cortisol in blood
  Other, incl cortisol6) X           6) as specified in Blood samples
  ECG 7) X           7) if indicated
  EEG X           
  MRI caput X           
Substance abuse Urin X           
Pregnancy Urin 8) X           8) fertile woman
Compliance Interview    X X X X X X X X  
Compliance Blood sample      X       
Temperament TEMPS-A          X   
Migrene Interview X         X