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

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

Detailed Description
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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.

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

Conditions
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Bipolar Disorder Depression

Intervention / Treatment
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* Drug: Vortioxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar Disorder, Depression, Bipolar, vortioxetine