This study aims at evaluating the effect of vortioxetine on cognitive dysfunction in major depressive disorder (MDD) patients with inadequate response to current antidepressant treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
101
FI005
Helsinki, Finland
FI001
Kuopio, Finland
FI006
Kupio, Finland
FI007
Tampere, Finland
Change in Digit Symbol Substitution Test (DSST)
The DSST is recognised as covering all of the cognitive performance aspects: speed of processing, executive functioning, and attention
Time frame: Baseline to Week 8
Change in Rey Auditory Verbal Learning Test (RAVLT)
Learning \[acquisition\] and memory \[delayed recall\])
Time frame: Baseline to Week 8
Change in Trail Making Test A (TMT-A)
Speed of processing
Time frame: Baseline to Week 8
Change in Trail Making Test B (TMT-B)
Executive functioning
Time frame: Baseline to Week 8
Change in Reaction time score; CRT attention
Time frame: Baseline to Week 8
Change in reaction time score SRT - simple reaction time
Time frame: Baseline to week 8
Change in STROOP incongruent score
Executive functioning
Time frame: Baseline to Week 8
Change in STROOP congruent score
Speed of processing
Time frame: Baseline to Week 8
Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score
Patient-reported cognitive function outcome including attention concentration, retrospective memory, prospective memory, and, planning organization
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FI004
Turku, Finland
DE005
Bochum, Germany
DE004
Mittweida, Germany
RS002
Belgrade, Serbia
RS003
Belgrade, Serbia
RS004
Belgrade, Serbia
...and 6 more locations
Time frame: Baseline to Week 8
Change in Patient Health Questionnaire-9 (depressive symptoms) (PHQ-9) total score
Patient-reported outcome
Time frame: Baseline to Week 8
Change in Clinical Global Improvement - Severity (CGI-S)
Time frame: Baseline to Week 8
Clinical Global Improvement (CGI-I)
Time frame: Week 8
Change in Functioning Assessment Short Test (FAST)
Time frame: Baseline to Week 8
Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Time frame: Baseline to Week 8