Bipolar Disorder Depression
Conditions
Keywords
Bipolar Disorder, Depression, Bipolar, vortioxetine
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.
Interventions
DRUGVortioxetine
Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
DRUGPlacebo
Augmentation : Placebo for week 1,2,4,6
Sponsors
H. Lundbeck A/S
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | 6 weeks | change of Montgomery-Asberg Depression Rating Scale (MADRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impressions (CGI) scale | 6 weeks | change of Clinical Global Impressions (CGI) scale |
| Digit Symbol Substitution Test (DSST) | 6 weeks | change of Digit Symbol Substitution Test (DSST) |
| Medication diary | 6 weeks | compliance assessment |
Countries
South Korea
Contacts
Primary ContactSang Jin Rhee, MD
Outcome results
None listed