Vortioxetine add-on Treatment Improves the Symptoms in Patients With Bipolar Depression
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to validate the efficacy of Vortioxetine augmentation in bipolar disorder patients with depressive symptoms.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Vortioxetine
Vortioxetine 5-20 mg
干预措施: Vortioxetine (Drug)
Placebo
Placebo augmentation
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 6 weeks
change of Montgomery-Asberg Depression Rating Scale (MADRS)
次要结局
- Medication diary(6 weeks)
- Clinical Global Impressions (CGI) scale(6 weeks)
- Digit Symbol Substitution Test (DSST)(6 weeks)
研究者
Yong Min Ahn
Professor
Seoul National University Hospital