Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
Overview
- Phase
- Phase 2
- Intervention
- Vortioxetine
- Conditions
- Bipolar Disorder Depression
- Sponsor
- Seoul National University Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Montgomery-Asberg Depression Rating Scale (MADRS)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Yong Min Ahn
Professor
Seoul National University Hospital
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
Arms & Interventions
Vortioxetine
Vortioxetine 5-20 mg
Intervention: Vortioxetine
Placebo
Placebo augmentation
Intervention: Placebo
Outcomes
Primary Outcomes
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 6 weeks
change of Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary Outcomes
- Medication diary(6 weeks)
- Clinical Global Impressions (CGI) scale(6 weeks)
- Digit Symbol Substitution Test (DSST)(6 weeks)