A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Evaluating the Effects of [Vortioxetine] Lu AA21004 Versus Agomelatine in Adult Patients Suffering From Major Depressive Disorder With Inadequate Response to Antidepressant Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 495
- 主要终点
- Change From Baseline in MADRS Total Score at Week 8
研究概览
简要总结
The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
- •The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
- •Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit and Baseline
- •The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception
排除标准
- •The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
- •The patient is at significant risk of suicide
- •The patient is currently receiving formal psychotherapy or other psychoactive medications
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine 10 mg or 20 mg
干预措施: Vortioxetine (Lu AA21004) (Drug)
Agomelatine 25 mg or 50 mg
干预措施: Agomelatine (Drug)
结局指标
主要结局
Change From Baseline in MADRS Total Score at Week 8
时间窗: Baseline and Week 8
The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.
次要结局
- Change From Baseline in MADRS Total Score at Week 12(Baseline and Week 12)
- Change From Baseline in HAM-A Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in HAM-A Total Score at Week 12(Baseline and Week 12)
- Change From Baseline in CGI-S Score at Week 8(Baseline and Week 8)
- Change From Baseline in CGI-S Score at Week 12(Baseline and Week 12)
- Change in Clinical Status Using CGI-I Score at Week 8(Week 8)
- Change in Clinical Status Using CGI-I Score at Week 12(Week 12)
- Proportion of Patients Who Respond at Week 8 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Baseline and Week 8)
- Proportion of Patients Who Respond at Week 12 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)(Baseline and Week 12)
- Proportion of Patients Who Are in Remission at Week 8 (Remission is Defined as a MADRS Total Score <=10)(Week 8)
- Proportion of Patients Who Are in Remission at Week 12 (Remission is Defined as a MADRS Total Score <=10)(Week 12)
- Change From Baseline in SDS Total Score at Week 8(Baseline and Week 8)
- Change From Baseline in SDS Total Score at Week 12(Baseline and Week 12)