Interventional, Open-label Effectiveness Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder Comorbid With Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 21
- 主要终点
- Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression coexisting with generalized anxiety disorder.
详细描述
100 patients, recruited from psychiatrist outpatient clinics are planned for enrolment. Approximately 50 of these patients will receive vortioxetine as a first treatment for the current Major Depressive Episode (MDE) (first treatment patients) and 50 patients will be switched to vortioxetine due to inadequate response to the current antidepressant medication treatment (switch patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient has a primary diagnosis of MDE, diagnosed according to DSM-5® confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has had the current MDE for <12 months
- •The patient has current comorbid Generalized Anxiety Disorder (GAD) according to DSM-5®. The diagnosis was made prior to the current MDE
- •The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥ 22 at the Baseline Visit
- •The patient has a Hamilton Anxiety Rating Scale (HAM-A) score ≥ 20 at the Baseline Visit
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
- •The patient has a history of previous major depressive episodes considered as treatment resistant, defined as inadequate response (incomplete or no therapeutic response) to two prior courses of at least 6 weeks of conventional antidepressant drugs in adequate dosages or, the patient has treatment-resistant depression in the investigator's opinion.
- •Other in- or exclusion criteria may apply
研究组 & 干预措施
Vortioxetine
10-20 mg vortioxetine tablets
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
时间窗: from baseline to Week 8
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
次要结局
- Change in Hamilton Anxiety Rating Scale (HAM-A) total score(from baseline to Week 8)
- Change in Hospital Anxiety and Depression Scale (HADS) total score(from baseline to Week 8)
- Change in Clinical Global Impression - Severity of Illness (CGI-S) score(from baseline to Week 8)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) total score(from baseline to Week 8)
- Clinical Global Impression Scale- Global Improvement (CGI-I) score(At Week 8)
- Change in Functioning Assessment Short Test (FAST) total score(from baseline to Week 8)