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

Bipolar Disorder Depression Clinical Trial

— ViBiD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03598868
• Other study ID #: AYM-ViBiD
• Status: Recruiting
• Phase: Phase 2
• Start date: August 8, 2018
• Est. completion date: September 25, 2021

Study information

• Verified date: August 2018
• Source: Seoul National University Hospital
• Contact: Sang Jin Rhee, MD
• Phone: 82 2 2072 2457
• Email: hellojr1123[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 25, 2021
• Est. primary completion date: September 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Bipolar Disorder Depression
• Depression
• Depressive Disorder

Intervention

Drug:
• Vortioxetine
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
• Placebo
Augmentation : Placebo for week 1,2,4,6

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	change of Montgomery-Asberg Depression Rating Scale (MADRS)	6 weeks
Secondary	Clinical Global Impressions (CGI) scale	change of Clinical Global Impressions (CGI) scale	6 weeks
Secondary	Digit Symbol Substitution Test (DSST)	change of Digit Symbol Substitution Test (DSST)	6 weeks
Secondary	Medication diary	compliance assessment	6 weeks