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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Bipolar Disorder Depression

Treatments: Drug: Placebo; Drug: Vortioxetine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03598868

AYM-ViBiD

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Vortioxetine

Experimental group

Description:

Vortioxetine 5-20 mg

Treatment:

Drug: Vortioxetine

Placebo

Placebo Comparator group

Description:

Placebo augmentation

Treatment:

Drug: Placebo