NCT03598868

Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.

Detailed description

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.

Conditions

• Bipolar Disorder Depression

Interventions

Type	Name	Description
DRUG	Vortioxetine	Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
DRUG	Placebo	Augmentation : Placebo for week 1,2,4,6

Timeline

• Start date: 2018-08-08
• Primary completion: 2021-09-25
• Completion: 2021-09-25
• First posted: 2018-07-26
• Last updated: 2018-08-10

Locations

2 sites across 1 country: South Korea