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

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

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder Depression
• Intervention / Treatment: Drug: Vortioxetine; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sang Jin Rhee, MD; Phone Number: 82 2 2072 2457; Email: hellojr1123@hanmail.net

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Not yet recruiting
    • Inha University Hospital
    • Contact: Hyeyoung Kim, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Yong Min Ahn, MD. PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vortioxetine; Vortioxetine 5-20 mg	Drug: Vortioxetine; Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.; Other Names: Brintellix®
Placebo Comparator: Placebo; Placebo augmentation	Drug: Placebo; Augmentation : Placebo for week 1,2,4,6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)	change of Montgomery-Asberg Depression Rating Scale (MADRS)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impressions (CGI) scale	change of Clinical Global Impressions (CGI) scale	6 weeks
Digit Symbol Substitution Test (DSST)	change of Digit Symbol Substitution Test (DSST)	6 weeks
Medication diary	compliance assessment	6 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2018
• Primary Completion (Anticipated): September 25, 2021
• Study Completion (Anticipated): September 25, 2021

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 16, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 8, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Bipolar Disorder; vortioxetine; Depression, Bipolar
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: AYM-ViBiD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No