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

NCT ID: NCT03598868

Last Updated: 2018-08-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2021-09-25

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.

Conditions

Bipolar Disorder Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vortioxetine

Vortioxetine 5-20 mg

Group Type: EXPERIMENTAL

Vortioxetine

Intervention Type: DRUG

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

Placebo

Placebo augmentation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Augmentation : Placebo for week 1,2,4,6

Interventions

Vortioxetine

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

Intervention Type: DRUG

Placebo

Augmentation : Placebo for week 1,2,4,6

Intervention Type: DRUG

Other Intervention Names

Brintellix®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yong Min Ahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong Min Ahn, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Inha University Hospital

Incheon, , South Korea

Site Status: NOT_YET_RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Jin Rhee, MD

Role: CONTACT

hellojr1123@hanmail.net

82 2 2072 2457

Facility Contacts

Hyeyoung Kim, MD

Role: primary

Yong Min Ahn, MD. PHD

Role: primary

Other Identifiers

AYM-ViBiD

Identifier Type: -

Identifier Source: org_study_id