| 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 | Inclusion/exclusion criteria | X |  |  |  |  |  |  |  |  |  |  |
NORBRAIN Entry Questionnaire NEQ | Socio demography Medical history etc | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
 | 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 | Â | Â | Â | Â | Â | Â | X | X | X | Â |
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 | Â | Â | Â | Â | Â | Â | Â | Â | X | X | Â |
Overall cognitive function | MMS 3) | Â | X | X | X | X | X | X | X | Â | Â | 3) in ECT-group only |
Neuropsychological assessment | Â | X | Â | Â | Â | Â | Â | Â | X | X | X | Â |
 | EMQ | X |  |  |  |  |  |  | X | X | X |  |
Adverse events | Interview UKU | Â | X4) | Â | Â | X | Â | Â | X | Â | Â | 4) previous med. |
 | SAE-form |  |  | X | X | X | X | X | X |  |  |  |
Lab | Cytokines | X | Â | Â | Â | Â | Â | Â | X | X | X | Â |
 | 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 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Pregnancy | Urin 8) | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | 8) fertile woman |
Compliance | Interview | Â | Â | X | X | X | X | X | X | X | X | Â |
Compliance | Blood sample | Â | Â | Â | Â | X | Â | Â | Â | Â | Â | Â |
Temperament | TEMPS-A | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â |
Migrene | Interview | X | Â | Â | Â | Â | Â | Â | Â | X | Â | Â |