Repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant major depression (TRMD) Veteran patients: study protocol for a randomized controlled trial

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 number^a						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	S^b	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

ISSN: 1745-6215