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

• Status: Unknown status
• Trial end date: 2021-09-25
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: H. Lundbeck A/S
• Treatments: Vortioxetine

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