Table 3.
Study timeline and tools
| Procedures and tools | T0 Enrolment phase (duration: 12 months) |
T1 (1 month) |
T2 (3 months) |
T3 (6 months) |
|---|---|---|---|---|
| Review of criteria for inclusion in the study | X | |||
| Informed consent document signed | X | |||
| Randomization (allocation to treatment and number assigned) | X | |||
| Recruitment form | X | |||
| ASEC | X | X | X | |
| MADRS | X | X | X | X |
| EQ-5D | X | X | X | X |
| CACI | X | X | X | X |
| SBT | X | X | X | X |
| Follow-up form | X | X | X | |
| Severe adverse event (SAE) form | ←← any time →→ | |||
ASEC Antidepressant Side-Effect Checklist, MADRS Montgomery–Åsberg Depression Rating Scale, EQ-5D Euroqol 5 Dimensions, CACI Charlson Age-Comorbidity Index, SBT Short Blessed Test