Measurement instruments | Assessment target | Time pointsa | |||||||
---|---|---|---|---|---|---|---|---|---|
Baseline | Intervention period | Follow-up | |||||||
< T0 | T1 | T2 | T4 | T6 | T7 | T8 | T10 | ||
Primary and secondary outcomes | |||||||||
 HDRS17 | Depressive symptoms (clinician-rated) | x |  | x | x | x | x | x | x |
 IDS-SR | Depressive symptoms (patient-rated) | x |  | x | x | x | x | x | x |
 CGI | Overall depression severity and change | x |  | x | x | x | x | x | x |
 SHAPS | Hedonic capacity | x |  |  |  | x |  |  | x |
 BSS | Suicidal ideation | x |  |  |  | x |  |  | x |
 AMT | Autobiographical memory | x |  |  |  | x |  |  | x |
 EQ-5D-5 L | Health related quality of life | x |  |  |  | x |  |  | x |
 QPE | Psychotic experiences | x | x |  |  | x |  |  | x |
 DSS | Dissociative features | x | x |  |  | x |  |  | x |
 ISDI | Sleep disturbance | x | x |  |  | x |  |  | x |
 SAFTEE | Side effects in any organ system | x | x | x | x | x | x | x | x |
 Physical examination | Heart rate, blood pressure, weight | x | x | x | x | x | x | x | x |
 Blood collection (I) | Liver enzyme levels | x |  |  |  | x |  |  |  |
 Demographics questionnaire | Demographics | x |  |  |  |  |  |  |  |
 DM-TRD | Treatment-resistance | x |  |  |  |  |  |  |  |
 NEO-FFI | Neuroticism | x |  |  |  |  |  |  |  |
 CEQ | Credibility and expectancy of intervention | x |  |  |  |  |  |  |  |
Additional outcomes | |||||||||
 BAI | Anxiety symptoms | x |  |  |  | x |  |  | x |
 GCPS | Pain | x |  |  |  | x |  |  | x |
 FTND | Nicotine dependence | x |  |  |  | x |  |  | x |
 Blood collection (II) | Biomarkers, gene expression, pharmacokinetics, CYP enzymes | x | x |  |  | x |  |  | x |
 Urine collection | Biomarkers | x |  |  |  | x |  |  | x |
 ZGV | Health care consumption | x |  |  |  | x |  |  | x |