Acute phase | |||||||
---|---|---|---|---|---|---|---|
0 | Week 2, day 14 (± 3) | Week 4, day 28 (± 3) | Telephone interview (week 6) | Week 8, day 56 (± 3) | Telephone interview, week 10 (for patients who change drugs in week 4) | Week 12 (± 7)/early termination | |
Informed consent | × | ||||||
Inclusion/exclusion criteria | × | ||||||
General data | × | ||||||
Medical history and mental symptoms | × | ||||||
MINI | × | ||||||
Somatic and neurological examination | × | ||||||
Vital signs/weight | × | × | × | ||||
QIDS-SR 16 | × | × | × | × | × | × | × |
FIBSER | × | × | × | × | × | × | × |
PDQ-9 | × | × | × | × | |||
SDS | × | × | × | × | |||
FBS | × | × | × | × | |||
Q-LES-Q-SF | × | × | × | × | |||
HAMD-17 | × | × | × | × | |||
YMRS | × | × | × | × | |||
Acceptability/feasibility | × | × | × | × | |||
Adverse reactions | × | × | × | × | × | × | |
Biological sample collection | × | × | × |