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

Phase 2

• Conditions: Bipolar Disorder Depression
• Interventions: Drug: Placebo; Drug: Vortioxetine

• Registration Number: NCT03598868
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2018-07-16
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-26
• Status Verified: 2018-08
• Study Start: 2018-08-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-08-10
• Primary Completion: 2021-09-25
• Study Completion: 2021-09-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients diagnosed with Bipolar I Disorder, Bipolar II Disorder, Other Specified Bipolar and Related Disorder, Unspecified Bipolar and Related Disorder by Diagnostic and Statistical Manual (DSM)-V criteria.
• 18 to 65 years of age
• Patients with Montgomery-Åsberg Depression Rating Scale score ≥ 23 (moderate to severe depression), after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics
• Patients with Young Mania Rating Scale score lower than 10, after 4 weeks or more of treatment by main medication of mood stabilizer or antipsychotics

Exclusion Criteria

• Currently experiencing manic, hypomanic, or mixed episode
• Comorbid with serious medical illness
• Comorbid with substance use disorder, medical illness or other neurologic disorder that may have caused depressive symptoms other than by bipolar disorder
• Pregnancy or Breastfeeding women
• Those who are hypersensitive to the main or other ingredient of the medication
• Currently on Monoamine oxidase (MAO) inhibitor or those who have discontinued MAO inhibitor in the last 14 days
• Severe liver disease, severe renal disease
• Bleeding tendency/disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo augmentation
Vortioxetine	Vortioxetine	Vortioxetine 5-20 mg

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	6 weeks	change of Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Name	Time	Method
Medication diary	6 weeks	compliance assessment
Clinical Global Impressions (CGI) scale	6 weeks	change of Clinical Global Impressions (CGI) scale
Digit Symbol Substitution Test (DSST)	6 weeks	change of Digit Symbol Substitution Test (DSST)

Trial Locations

Locations (2)

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of