Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
ViBiD
1 other identifier
interventional
100
1 country
2
Brief Summary
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2018
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedStudy Start
First participant enrolled
August 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 25, 2021
CompletedAugust 10, 2018
August 1, 2018
3.1 years
July 16, 2018
August 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Montgomery-Asberg Depression Rating Scale (MADRS)
change of Montgomery-Asberg Depression Rating Scale (MADRS)
6 weeks
Secondary Outcomes (3)
Clinical Global Impressions (CGI) scale
6 weeks
Digit Symbol Substitution Test (DSST)
6 weeks
Medication diary
6 weeks
Study Arms (2)
Vortioxetine
EXPERIMENTALVortioxetine 5-20 mg
Placebo
PLACEBO COMPARATORPlacebo augmentation
Interventions
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
Eligibility Criteria
You may qualify if:
- 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.
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- H. Lundbeck A/Scollaborator
Study Sites (2)
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yong Min Ahn, MD, PHD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 16, 2018
First Posted
July 26, 2018
Study Start
August 8, 2018
Primary Completion
September 25, 2021
Study Completion
September 25, 2021
Last Updated
August 10, 2018
Record last verified: 2018-08