To assess the efficacy of acute treatment with 10 mg/day vortioxetine versus placebo on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning, attention) in working patients with major depressive disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
152
EE001
Tallinn, Estonia
EE002
Tallinn, Estonia
EE004
Võru, Estonia
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Time frame: Baseline to Week 8
Change in Trail Making Test (TMT) score: TMT-A; speed of processing
Time frame: Baseline to Week 8
Change in TMT-B; executive functioning
Time frame: Baseline to Week 8
Change in reaction time score: Choice Reaction Time (CRT); attention
Time frame: Baseline to Week 8
Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed)
Time frame: Baseline to Week 8
Change in Stroop Colour Naming Test (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
Time frame: Baseline to Week 8
Change in Montgomery and Asberg Depression Rating Scale (MADRS) total score
Time frame: Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)
Time frame: Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score
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FI002
Helsinki, Finland
FI003
Helsinki, Finland
FI001
Kuopio, Finland
FI008
Oulu, Finland
FI007
Tampere, Finland
DE002
Berlin, Germany
DE001
Bielefeld, Germany
...and 8 more locations
Time frame: Week 8
Change in the Functioning Assessment Short Test (FAST) total score
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