Table 2.
Study flow chart
| Study period | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre-Treatment | Treatment | Follow-up | |||||||||||
| Week | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 10 | 18 | ||||
| Visit | Screening | Baseline | V1-V5 | V6-V10 | V10 | V11-V15 | V16-V20 | V20 | V21-V25 | V26-V30 | V30 | V31 | V32 |
| Informed consent | X | ||||||||||||
| Sociodemography | X | ||||||||||||
| Pregnancy test1 | X | ||||||||||||
| Physical/neurological examination | X | ||||||||||||
| Concomitant treatment2 | X | X | X | X | X | X | X | ||||||
| SCID-5-PD | X | ||||||||||||
| ATHF-SF | X | ||||||||||||
| MADRS (item 10 only) | X | ||||||||||||
| HDRS-17 | X | X | X | X | X | X | |||||||
| Randomization | X | ||||||||||||
| MADRS (complete) | X | X | X | X | X | X | |||||||
| BDI-II | X | X | X | X | X | X | |||||||
| CGI | X | X | X | X | X | X | |||||||
| WHO-5 | X | X | X | X | |||||||||
| WPAI | X | X | X | ||||||||||
| THINC-it® (test of cognition) | X | X | X | ||||||||||
| CTQ | X | ||||||||||||
| EHI | X | ||||||||||||
| MRI3 | X | ||||||||||||
| Genetics3 | X | X | X | ||||||||||
| Determination of resting motor threshold4 | X | ||||||||||||
| Active iTBS/cTBS sham iTBS/cTBS |
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| Safety check |
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1Pregnancy test is only necessary for women in child-bearing age; if a blood sample is taken as part of the clinical routine, it is advisable to check a possible pregnancy with a blood test. Otherwise, a urine test can be used to avoid unnecessary risks
2Concomitant medication and/or any type of psychotherapy will be documented for each patient for his/her entire participation period
3MRI and Genetics are not part of the standard protocol but belong to two satellite projects
4Alternatively, the threshold can also be determined directly before the first stimulation, i.e. in visit 1