To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
151
EE001
Tallinn, Estonia
EE002
Tallinn, Estonia
FI002
Helsinki, Finland
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
Time frame: Baseline to Week 8
Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])
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 score: 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 Hamilton Depression Rating Scale-17 (HAMD-17) total score
Time frame: Baseline to Week 8
Change in Clinical Global Impression - Severity of Illness (CGI-S)
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FI003
Helsinki, Finland
FI005
Helsinki, Finland
FI001
Kuopio, Finland
FI006
Kupio, Finland
FI004
Turku, Finland
DE002
Berlin, Germany
DE001
Bielefeld, Germany
...and 7 more locations
Time frame: Baseline to Week 8
Clinical Global Impression - Global Improvement (CGI-I) score
Time frame: Week 8
Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score
Time frame: Baseline to Week 8
Number of adverse events
Time frame: Baseline to Week 12
Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions (1, 2, 3, 4 and 7)
Time frame: Baseline to Week 8