The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
In this study, the investigators are going to examine the efficacy of vortioxetine augmentation in bipolar disorder patients with depressive symptoms. The study design is a double-blinded 6-week prospective study. It would be useful for clinicians because it will provide new evidence for the effect of vortioxetine in bipolar disorder patients with depressive symptoms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
Augmentation : Placebo for week 1,2,4,6
Inha University Hospital
Incheon, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGMontgomery-Asberg Depression Rating Scale (MADRS)
change of Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 6 weeks
Clinical Global Impressions (CGI) scale
change of Clinical Global Impressions (CGI) scale
Time frame: 6 weeks
Digit Symbol Substitution Test (DSST)
change of Digit Symbol Substitution Test (DSST)
Time frame: 6 weeks
Medication diary
compliance assessment
Time frame: 6 weeks
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