Randomised Placebo-controlled Venlafaxine-referenced Study of Efficacy and Safety of 5 and 10 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
2014年4月22日 更新者：H. Lundbeck A/S
Double-blind, Randomised, Placebo-controlled Study Comparing the Efficacy and Safety of Two Fixed Dosages of a Novel Antidepressant Compound to That of Placebo in Patients With Major Depressive Disorder
The purpose of this Venlafaxine-referenced study is to evaluate the efficacy, safety and tolerability of two fixed doses of Vortioxetine in the acute treatment of Major Depressive Disorder (MDD).
研究概览
研究类型
介入性
注册 (实际的)
426
阶段
- 阶段2
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- MDE as primary diagnosis according to DSM-IV-TR criteria (classification code 296.xx)
- Current MDE duration of at least 3 months and less than 12 months
- The patient has a MADRS total score >=30
Exclusion Criteria:
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Female patients of childbearing potential who are not using effective contraception
- Use of any psychoactive medication 2 weeks prior to screening and during the study
Other protocol-defined inclusion and exclusion criteria may apply.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂
|
胶囊，每日一次，口服
|
|
实验性的：Vortioxetine (Lu AA21004) 5 mg
|
胶囊化片剂，每日一次，口服
其他名称：
|
|
实验性的：Vortioxetine (Lu AA21004) 10 mg
|
胶囊化片剂，每日一次，口服
其他名称：
|
|
其他：Venlafaxine XL 225 mg
Active Reference
|
capsules, daily, orally
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in MADRS Total Score After 6 Weeks of Treatment
大体时间：Baseline and Week 6
|
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.
|
Baseline and Week 6
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in MADRS Total Score After 1 Week of Treatment
大体时间：Baseline and Week 1
|
Baseline and Week 1
|
|
|
Change From Baseline in HAM-D 24 Total Score After 6 Weeks of Treatment
大体时间：Baseline and Week 6
|
The 24-item Hamilton Depression Rating Scale (HAM-D) is based on the 21-item HAM-D plus an additional 3 items (helplessness, hopelessness, and worthlessness).
The observer makes his/her assessment on the basis of a specific statement, content, tone, facial expression, and gestures of the patient during the interview, and scores each item from 0 to 2 or 0 to 4. Total score from 0 to 76.
The higher the score, the more severe.
|
Baseline and Week 6
|
|
Change From Baseline in HAM-A Total Score After 6 Weeks of Treatment
大体时间：Baseline and Week 6
|
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items that assess anxious mood, tension, fear, insomnia, intellectual (cognitive) symptoms, depressed mood, behaviour at interview, somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic, and somatic (muscular) symptoms.
Each symptom is rated from 0 (absent) to 4 (maximum severity).
Total score from 0 to 56.
The higher the score, the more severe.
|
Baseline and Week 6
|
|
Change From Baseline in CGI-S Score After 6 Weeks of Treatment
大体时间：Baseline and Week 6
|
The Clinical Global Impression - Severity of Illness (CGI-S) is a 7-point scale rated from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
The investigator should use his/her total clinical experience with this patient population to judge how mentally ill the patient is at the time of rating.
|
Baseline and Week 6
|
|
Change in Clinical Status Using CGI-I Score at Week 6
大体时间：Week 6
|
The Clinical Global Impression - Global Improvement (CGI-I) is a 7-point scale rated from 1 (very much improved) to 7 (very much worse).
The investigator rated the patient's overall improvement relative to baseline, whether or not, in the opinion of the investigator, this was entirely due to the drug treatment.
|
Week 6
|
|
Proportion of Responders at Week 6 (Response Defined as a >=50% Decrease in the MADRS Total Score From Baseline)
大体时间：Week 6
|
Week 6
|
|
|
Proportion of Remitters at Week 6 (Remission is Defined as a MADRS Total Score <=10)
大体时间：Week 6
|
Week 6
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年8月1日
初级完成 (实际的)
2007年8月1日
研究完成 (实际的)
2007年9月1日
研究注册日期
首次提交
2009年2月6日
首先提交符合 QC 标准的
2009年2月6日
首次发布 (估计)
2009年2月9日
研究记录更新
最后更新发布 (估计)
2014年5月13日
上次提交的符合 QC 标准的更新
2014年4月22日
最后验证
2014年4月1日
更多信息
与本研究相关的术语
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.