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Table 3 Study timeline and tools

From: Tolerability and efficacy of vortioxetine versus SSRIs in elderly with major depression. Study protocol of the VESPA study: a pragmatic, multicentre, open-label, parallel-group, superiority, randomized trial

Procedures and tools

T0

Enrolment phase

(duration: 12 months)

T1

(1 month)

T2

(3 months)

T3

(6 months)

Review of criteria for inclusion in the study

X

   

Informed consent document signed

X

   

Randomization (allocation to treatment and number assigned)

X

   

Recruitment form

X

   

ASEC

 

X

X

X

MADRS

X

X

X

X

EQ-5D

X

X

X

X

CACI

X

X

X

X

SBT

X

X

X

X

Follow-up form

 

X

X

X

Severe adverse event (SAE) form

 

←← any time →→

  1. ASEC Antidepressant Side-Effect Checklist, MADRS Montgomery–Åsberg Depression Rating Scale, EQ-5D Euroqol 5 Dimensions, CACI Charlson Age-Comorbidity Index, SBT Short Blessed Test
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Trials

ISSN: 1745-6215