Table 3.
Study performance and data element assessment scheme
| Assessment (domain) and specific measurement | Weeks 2–4 | Acute treatment phase | Follow-up phase | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4–11 weeks | 24 weeks | |||||||||||||||
| End of session numbera | Taper | Follow up | ||||||||||||||
| 5 | 10 | 15 | 20 | [25] | [30] | 1 | 2 | 3 | 4 | 8 | 12 | 16 | 20 | 24 | ||
| Consent | S* | |||||||||||||||
| Screening | S | |||||||||||||||
| Randomization | B* | |||||||||||||||
| Baseline | S | |||||||||||||||
| Medical history | S | |||||||||||||||
| Physical exam | S | x | ||||||||||||||
| Laboratory measurements | S | |||||||||||||||
| SCID-I | S | |||||||||||||||
| Current/past ATHF | S | |||||||||||||||
| Lifetime drinking history | B | |||||||||||||||
| CAPS | B | x | x | |||||||||||||
| THQ | B | |||||||||||||||
| LSC-R | B | |||||||||||||||
| BOMC | S | |||||||||||||||
| Medication use | S | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
| rTMS treatment log | x | x | x | x | x | x | ||||||||||
| rTMS taper log | x | x | x | |||||||||||||
| HRSD and MADRS | Sb | x | x | x | x | x | x | x | x | x | x | x | x | |||
| BDI | B | x | x | x | x | x | x | x | x | x | x | x | x | |||
| QIDS-C16 | B | x | x | x | x | x | x | x | x | x | x | x | x | |||
| C-SSRS | S | |||||||||||||||
| C-SSRS follow up | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x | |
| BSS | S | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
| BHS | S | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
| VR-36 | B | x | x | |||||||||||||
| Neuropsychological battery | B | x | x | |||||||||||||
| DAST | S | x | x | |||||||||||||
| PCL | B | x | x | |||||||||||||
| MAST | S | x | x | |||||||||||||
| STAXI-2 | S | x | x | x | x | x | x | x | x | x | x | x | x | x | x | x |
| Urine toxicology screen and alcohol test | S | x | x | X | x | x | x | x | ||||||||
| Protocol deviation | As required | |||||||||||||||
| AE/SAE/UADE | As required | |||||||||||||||
Note, for primary analyses and descriptive statistics total scores are used. Abbreviations: SCID Structured Clinical Interview for DSM Disorders, ATHF Antidepressant Treatment History Form, CAPS Clinician Administered PTSD Scale, THQ Trauma History Questionnaire, LSC-R Life Stressor Checklist-revised, BOMC Six-Item Blessed Orientation-Memory-Concentration, rTMS Repetitive transcranial magnetic stimulation, HRSD Hamilton Rating Scale for Depression, MADRS Montgomery-Asberg Depression Rating Scale, BDI Beck Depression Inventory, QIDS-C16 Quick Inventory of Depressive Symptomatology, C-SSRS Columbia Suicide Severity Rating Scale, BSS Beck Scale for Suicide Ideation, BHS Beck Hopelessness Scale, VR-36 Veterans RAND 36-Item Health Survey, DAST Drug Abuse Screening Test, PCL Posttraumatic Stress Disorder Checklist, MAST Michigan Alcohol Screening Test, STAXI-2 State Trait Anger Expression Inventory-2, AE adverse events, SAE serious adverse events
*B Baseline
*S Screening
aSessions 21–25 and 26 − 30 may not be required if patient goes into remission earlier
bMust be conducted within 7 days prior to randomization