Day | Pre-study | Run-in phase | Treatment phase | Follow-up | Clinic discharge | |||||
---|---|---|---|---|---|---|---|---|---|---|
−8 | −7 | −7–0 | 0 | 7 | 14 | 21 | 28 | 35, 42.. | ||
Informed consent for trial participation | x | |||||||||
Eligibility (pregnancy test, drug screening, inclusion, & exclusion criteria) | x | |||||||||
Buccal swab (Stratipharm®) | x | |||||||||
Medical history (previous antidepressant therapies) | x | |||||||||
Lab values (basic hematology, creatinine (eGFR), ASAT, ALAT, total bilirubin, gamma-GT, CRP, TSH, vit. B12, and vit. D) | x | x | ||||||||
Concomitant medication documentation | x | x | x | x | x | x | x | x | ||
RANDOMIZATION (only if new antidepressant indicated) | x | |||||||||
PGx pharmaceutical recommendation (only arm A) | x | |||||||||
Start NEW antidepressant | x | |||||||||
HAM-D17 | x | xa | xc | x | xc | x | x | x | ||
AE assessment (antidepressant therapy only) | xc | x | xc | x | x | x | ||||
FIBSER patient self-assessment | xa | xc | x | xc | x | x | x | |||
BDI-II patient self-assessment | xa | x | x | xb | x | |||||
Blood sample collection (EDTA and serum) | x | x |