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Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder

2014年11月4日 更新者：Takeda

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase III Study to Assess the Efficacy and Safety of Lu AA21004 in Patients With Major Depressive Disorder

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Vortioxetine (Lu AA21004), once daily (QD), in Japanese participants with major depressive disorder.

The purpose of this study is to assess the efficacy, safety and tolerability of 8-week treatment with Lu AA21004, once daily (QD), in Japanese participants with major depressive disorder.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder. Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy. This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period. Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study. Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

Lu AA21004 was discovered by H. Lundbeck A/S, and is under co-development by H. Lundbeck A/S and Takeda for the treatment of major depressive disorder and general anxiety disorder.

Major depressive disorder (MDD) is a chronic, recurring disease with considerable morbidity in the general population. The estimated lifetime prevalence of major depression in the adult population is 5 to 25%, with approximately 2-fold higher prevalence in women than in men. The hallmark of the disease is a depressed mood, with additional symptoms including sleep disturbances, psychomotor agitation or retardation, sexual dysfunction, weight loss, concentration difficulties and delusional ideas. In addition to direct ill effects, MDD causes suicide or job loss and exerts indirect influence on social economy.

This study will assess the efficacy and the safety of Lu AA21004. This study consists of a 1-week screening period, an 8-week double-blind treatment period, 4-week s safety follow-up.The duration of the study is 13 weeks in total. Blood samples will be collected from participants, and a safety follow-up contact (visit or phone call) will be made 4 weeks after completion of the 8-week double-blind treatment period.

Subjects who complete the 8-week double-blind treatment period can successively enter a long-term extension study (Lu AA21004/OCT-001; NCT01395147; hereinafter, OCT-001), if they meet all inclusion criteria and none of exclusion criteria of the OCT-001 study and are willing to participate in the OCT-001 study.

Subjects who will enter the OCT-001 will not be requested to safety follow-up after completion of the 8-week double-blind treatment period.

研究类型

介入性

注册 (实际的)

366

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 日本
      • Ibaraki、日本
      • Tokyo、日本
    • Chiba
      • Inzai-shi、Chiba、日本
      • Noda-City、Chiba、日本
    • Fukuoka
      • Fukuoka-city、Fukuoka、日本
      • Kitakyushu-shi、Fukuoka、日本
    • Gunma
      • Annaka-shi、Gunma、日本
      • Fujioka-shi、Gunma、日本
      • Takasaki-shi、Gunma、日本
    • Hiroshima
      • Hatsukaichi-shi、Hiroshima、日本
      • Hiroshima-shi、Hiroshima、日本
    • Hokkaido
      • Sapporo-Shi、Hokkaido、日本
    • Hyogo
      • Amagasaki-shi、Hyogo、日本
      • Kobe-shi、Hyogo、日本
    • Kanagawa
      • Fujisawa-shi、Kanagawa、日本
      • Kawasaki-shi、Kanagawa、日本
      • Sagamihara-shi、Kanagawa、日本
      • Yokohama-shi、Kanagawa、日本
    • Kita-ku
      • Osaka-shi、Kita-ku、日本
    • Kumamoto
      • Kumamoto-shi、Kumamoto、日本
    • Kyoto
      • Kyoto-shi、Kyoto、日本
    • Okayama
      • Kurashiki-shi、Okayama、日本
    • Osaka
      • Osaka-shi、Osaka、日本
    • Saitama
      • Fukaya-shi、Saitama、日本
      • Saitama-city、Saitama、日本
    • Tochigi
      • Utsunomiya-shi、Tochigi、日本
    • Tokushima
      • Anan-shi、Tokushima、日本
      • Tokushisma-shi、Tokushima、日本
    • Tokyo
      • Hachioji-shi、Tokyo、日本
      • Katsushika-ku、Tokyo、日本
      • Musashino-shi、Tokyo、日本
    • Yamagata
      • Nanyo-shi、Yamagata、日本

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

20年 至 75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:

  1. The subject suffers from Major Depressive Disorder (MDD) as the primary diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.2x and 296.3x).
  2. The reported duration of the current major depressive episode is at least 3 months at the Screening Visit.
  3. The subject has a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Screening and Baseline Visits.
  4. The subject has a Clinical Global Impression Scale-Severity (CGI-S) score ≥4 at the Screening and Baseline Visits

Exclusion Criteria:

  1. The subject has one or more of the following conditions:

    • Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR. A subject who exhibits symptoms of anxiety is eligible unless the subject fulfills the diagnostic criteria for a current anxiety disorder per DSM-IV-TR.
    • Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
    • Current diagnosis or history of any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
    • Presence or history of a clinically significant neurological disorder (including epilepsy).
    • Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
    • Any DSM-IV-TR axis II disorder that might compromise the study.
  2. The current depressive symptoms of the subject are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
  3. The subject is at significant risk of suicide or has a score ≥5 on Item 10 (suicidal thoughts) of the MADRS at the Screening and Baseline Visit, or has attempted suicide within 6 months prior to the Screening Visit.

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Vortioxetine 5 mg
Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
药品：沃替西汀
沃替西汀片
其他名称：
  • 鲁AA21004
  • 布林泰利
实验性的：Vortioxetine 10 mg
Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
药品：沃替西汀
沃替西汀片
其他名称：
  • 鲁AA21004
  • 布林泰利
安慰剂比较：Placebo
Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
药品：Placebo
Vortioxetine placebo
其他名称：
  • Vortioxetine placebo-matching tablets

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 Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score After 8 Weeks of Treatment
大体时间：Baseline, Week 8
MADRS is a 10-item clinician rated scale that measures overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. A negative change from Baseline indicates that symptoms have improved. An analysis of covariance (ANCOVA) model was used with change in MADRS total score as a dependent variable, treatment as a fixed effect and the baseline MADRS total score as a covariate.
Baseline, Week 8

次要结果测量

结果测量
措施说明
大体时间
Percentage of Patients With MADRS Response After 8 Weeks of Treatment
大体时间：Baseline, Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Response is defined as a ≥50% decrease in the MADRS Total Score from Baseline.
Baseline, Week 8
Percentage of Patients With MADRS Remission After 8 Weeks of Treatment
大体时间：Week 8
MADRS is a 10-item clinician rated scale to measure overall severity of depressive symptoms (such as apparent sadness, reported sadness, inner tension) rated on a 7-point Likert scale from 0 (symptoms absent) to 6 (severe depression) with a total possible score range from 0 to 60. Higher scores indicate greater severity of symptoms. Remission is defined as a MADRS Total Score ≤10.
Week 8
Change From Baseline in the Hamilton Depression Scale (HAM-D17) Total Score After 8 Weeks of Treatment
大体时间：Baseline, Week 8
The HAM-D17 is a 17-item rating scale that assesses depressed mood, agitation and somatic symptoms of depression, rated on a 5-point scale from 0 (absent) to 4 (very severe) with a total score range from 0 to 52. Higher scores indicate greater severity of depression symptoms. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the baseline HAM-D17 score as a covariate.
Baseline, Week 8
Clinical Global Impression Scale-Improvement (CGI-I) Score After 8 Weeks of Treatment
大体时间：Baseline, Week 8
The CGI-I assesses the clinician's impression of the participant's state of mental illness improvement and consists of one question for the investigator: "Compared to his condition at the start of the study, how much has this patient changed?" which is rated on a seven-point scale (1=very much improved; 2=much improved; 3=minimally improved; 4=no change from baseline; 5=minimally worse; 6= much worse; 7=very much worse). Higher scores indicate greater severity of illness. Values closest to 1 for this outcome measure indicate the greatest improvement of symptoms. ANCOVA model was used with treatment as a fixed effect and the baseline CGI-Severity (CGI-S) score as a covariate.
Baseline, Week 8
Change From Baseline in Sheehan Disability Scale (SDS) Total Score After 8 Weeks of Treatment
大体时间：Baseline, Week 8
The SDS is a 3 item rating scale to assess functional impairment (panic, anxiety, phobic and depressive symptoms) over three inter-related domains (work/school, social life, and family life/home responsibilities) rated on an 11 point scale from 0 (not at all) to 10 (extremely) with a total score range from 0 to 30. Higher scores indicate greater severity of impairment. A negative change from Baseline indicates that symptoms have improved. ANCOVA model was used with treatment as a fixed effect and the Baseline SDS total score as a covariate.
Baseline, Week 8

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。

赞助

Takeda

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。

一般刊物

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

2011年5月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2011年5月16日

首先提交符合 QC 标准的

2011年5月16日

首次发布 (估计)

2011年5月17日

研究记录更新

最后更新发布 (估计)

2014年11月11日

上次提交的符合 QC 标准的更新

2014年11月4日

最后验证

2014年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • LuAA21004/CCT-003
  • U1111-1120-9277 (注册表标识符：WHO)
  • JapicCTI-111492 (注册表标识符：JapicCTI)

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.

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