|
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
