The effects of using the PReDicT Test to guide the antidepressant treatment of depressed patients: study protocol for a randomised controlled trial

Table 2 Time and events table – clinical phase activities

	Visit 1: screening and PReDicT #1	Treatment start date	PReDicT #2	Visit 2 (if required)	Change of dose start date^a (if required)	PReDicT #3 (if required)	Visit 3 (if required)	Change of medication start date^b (if required)	Visit 4^c
Requirements for timing of visit/event	Within 7 days of initial consultation	Day 0	≥7 days after day 0			≥ 7 days after changed dose			≥ 8–10 weeks after day 0
Preferred timing		Day 0	7–9 days after day 0	0–1 day after PReDicT #2	0–1 day after visit 2	7–9 days after changed dose	0–1 day after PReDicT #3	0–1 day after visit 3	8 weeks after day 0
Informed consent	X
Entry criteria check	X
Change in antidepressant (AD) medication agreed				X^a			X^b
Review of concomitant medication									X
Review of AEs, ADEs and device deficiencies	X								X
Assessments
PReDicT Test	X		X			X^a
QIDS-SR-16	X^d	Completed weekly, starting 7 days after day 0							X^d
Randomisation	X
EQ-5D-5 L	X								X
HEQ	X								X
OxCAP-MH (UK and Germany only)	X								X
SAS-SR (screener version)	X								X
GAD-7	X								X
DSST	X								X
MADRS	X								X
Patient Acceptability Questionnaire									X

^aIf PReDicT #2 outcome = non-response, physician decides if antidepressant will be changed. PReDicT #3 will be completed
^bIf PReDicT #3 outcome = non-response physician decides if antidepressant will be changed
^cParticipants who withdraw will be invited to complete (in order of preference): visit 4 (at 8-week time point); visit 4 online questionnaires (from home at 8-week time point); Patient Acceptability Questionnaire (immediately); no additional data
^dQIDS-SR-16 is included in the PReDicT Test
AE adverse event, ADE Adeverse Device Event, EQ-5D-5 L 5-dimensional, 5-level EuroQoL health-related quality of life questionnaire, DSST Digit Symbol Substitution Test, GAD-7 Generalised Anxiety Disorder Questionnaire, 7-item version, HEQ Health Economics Questionnaire, OxCAP-MH Oxford CAPabilities questionnaire-Mental Health, MADRS Montgomery-Åsberg Depression Rating Scale, QIDS Quick Inventory of Depressive Symptomatology – Self Report

ISSN: 1745-6215