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

Primary Purpose

Bipolar Disorder Depression

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vortioxetine
Placebo
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder Depression focused on measuring Bipolar Disorder, Depression, Bipolar, vortioxetine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Inha University Hospital
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vortioxetine

Placebo

Arm Description

Vortioxetine 5-20 mg

Placebo augmentation

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
change of Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Clinical Global Impressions (CGI) scale
change of Clinical Global Impressions (CGI) scale
Digit Symbol Substitution Test (DSST)
change of Digit Symbol Substitution Test (DSST)
Medication diary
compliance assessment

Full Information

First Posted
July 16, 2018
Last Updated
August 8, 2018
Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03598868
Brief Title
Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Acronym
ViBiD
Official Title
Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
September 25, 2021 (Anticipated)
Study Completion Date
September 25, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
H. Lundbeck A/S

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder Depression
Keywords
Bipolar Disorder, Depression, Bipolar, vortioxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vortioxetine
Arm Type
Experimental
Arm Description
Vortioxetine 5-20 mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo augmentation
Intervention Type
Drug
Intervention Name(s)
Vortioxetine
Other Intervention Name(s)
Brintellix®
Intervention Description
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Augmentation : Placebo for week 1,2,4,6
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
change of Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impressions (CGI) scale
Description
change of Clinical Global Impressions (CGI) scale
Time Frame
6 weeks
Title
Digit Symbol Substitution Test (DSST)
Description
change of Digit Symbol Substitution Test (DSST)
Time Frame
6 weeks
Title
Medication diary
Description
compliance assessment
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Jin Rhee, MD
Phone
82 2 2072 2457
Email
hellojr1123@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD, PHD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyeyoung Kim, MD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Min Ahn, MD. PHD

12. IPD Sharing Statement

Learn more about this trial

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

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