Efficacy of Vortioxetine on Cognitive Functioning in Working Patients with Major

Depressive Disorder
Objective
(Major Depressive Disorder : MDD )

vortioxetine Cognitive function MDD

Method
Study population for investigation of effect on cognitive functioning
study design Double-blind, randomized ,fixed-dose ,placebo-controlled
study vortioxetine 10 20 mg/day placebo
MDD moderate to severe
12
(Australia,Canada,Finland,France,Germany,Latvia,Mexico,Serbia,Slovakia,South Africa, Ukraine
and USA) 2011 2013
1.18-65
2. MDD recurrent MDD DSM-IV-TR
current MDE 3
3.MADRS total score 26 baseline
working status Health Economic assessment (HEA) questionnaire
3 1.all patients 2.working patients (
, ) 3.Professional (,,)

Study population for investigation of effect Depressive functioning

Depressive symptoms FOCUS study , 3 short-term
randomized placebo controlled study (Baldwin et al, Henigsberg et al, Boulenger et al)
relapse prevention study population

Clinical assessment
Cognitive function Objective data neuropsychological test
Digit Symbol Substitution test (DSST)

Rey Auditory Verbal Learning Test (RAVLT) ,
Trail Making Test A (TMT-A)
Trail Making Test B (TMT-B)
Stroop test
Simple reaction time task (SRT)
Choice reaction time task (CRT)
Subjective data Patient reported Perceived Deficits
Questionnaire (PDQ)
Depressive Symptom Montgomery-Asberg Depression Rating Scale (MADRS)
Absolute values

Statistical Analysis
Baseline
8 ANCOVA LOCF
baseline
DSST baseline
MADRS cognitive function
antidepressant baseline
MADRS MMRM
meta-analysis standard random antidepressant
MARDS FOCUS 3 short-term randomized placebo
controlled study Relapse
Cox proportional hazard model Placebo

Result
Baseline characteristics
4 short-term clinical studies (
vortioxetine 1,2.5 mg ) 2,206 working patients 1,254
(57%) relapse prevention 396 working
patients 234 (59%)
Baseline characteristics all patients working patients
Baseline scores of neuropsychological test placebo, vortioxetine
10 mg vortioxetine 20 mg

Clinical Outcome
 cognitive function (FOCUS study)
DSST cognitive function vortioxetine
placebo 8
all patients vortioxatine 10 mg 4.0
baseline (p<0.01) vortioxatine 20 mg 4.0 baseline
(p<0.01)
working patients vortioxatine 10 mg 5.68
baseline (p<0.01) vortioxatine 20 mg 5.0 baseline
(p<0.01)
Professional patients vortioxatine 10 mg 9.2
baseline (p=0.006) vortioxatine 20 mg 9.0
baseline (p=0.01)
Professional patients vortioxatine
working patients vortioxatine cognitive function
TMT-A , TMT-B , SRT , stroop significant
DSST
subjective reporting of cognitive function Perceived deficits
Questionnaire (PDQ)
all patients vortioxatine 10 mg -4.4
baseline (p<0.01) vortioxatine 20 mg -5.7 baseline (p<0.01)
working patients vortioxatine 10 mg -4.9
baseline (p=0.006) vortioxatine 20 mg -5.7 baseline
(p<0.01)
Professional patients vortioxatine 10 mg -8.3
baseline (p=0.048) vortioxatine 20 mg -11.5
baseline (p=0.002)
Professional patients vortioxatine
working patients vortioxatine cognitive function

depressive symptoms severity (FOCUS study)

MADRS depressive symptoms severity
baseline vortioxetine placebo
all patients vortioxatine 10 mg -4.6
baseline (p<0.001) vortioxatine 20 mg -6.6 baseline
(p<0.001)
 working patients vortioxatine 10 mg -5.7
baseline (p<0.001) vortioxatine 20 mg -7.3 baseline
(p<0.001)
Professional patients vortioxatine 10 mg -9.6
baseline (p<0.001) vortioxatine 20 mg -12.0
baseline (p<0.001)
Professional patients vortioxatine
working patients vortioxatine depressive symptoms

meta-analysis FOCUS study 3 short-term

placebo-controlled study MADRS
vortioxetine placebo all patients -3.39 -6.79 (p<0.001) working
patients -3.79 -7.27 (p<0.001) professional patients -4.68
-9.81 (p<0.015)
relapse prevention placebo relapse
vortioxetine (p=0.006)

Discussion
vortioxetine Cognitive function
MDD
antidepressant MDD
vortioxetine MDD
Cognitive function
neuropsychological test Professional

MDD
vortioxetine

vortioxetine
( DSST, TMT-A, SRT, CRT)
vortioxetine
"Professional"
(DSST, Stroop
 TMT-B)
cognitive
Vortioxetine

European Depression Association 1 10
( 35.9 ) 1 3
MDD
Cognitive symptom
working
nonworking

working MDD
nonworking MDD ,

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