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

NCT03598868 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2018-08-10

No results posted yet for this study

Summary

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

Conditions

  • Bipolar Disorder Depression

Interventions

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    collaborator INDUSTRY
  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yong Min Ahn, MD, PHD · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2021-09-25
Completion
2021-09-25

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598868 on ClinicalTrials.gov