A Study of Aripiprazole in Patients With Major Depressive Disorder
2013年11月7日 更新者：Otsuka Pharmaceutical Development & Commercialization, Inc.
The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of aripiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed antidepressant therapy.
研究概览
研究类型
介入性
注册 (实际的)
349
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
-
-
Alabama
-
Birmingham、Alabama、美国、35205
- University of Alabama at Birmingham
-
-
California
-
San Diego、California、美国、92123
- Sharp Mesa Vista Hospital
-
-
District of Columbia
-
Washington、District of Columbia、美国、20037
- George Washington University Medical Center
-
-
Florida
-
Coral Springs、Florida、美国、33065
- CNS Clinical Research Group
-
-
Georgia
-
Augusta、Georgia、美国、30912
- Medical College of Georgia
-
Smyrna、Georgia、美国、30080
- Carman Research
-
-
Illinois
-
Chicago、Illinois、美国、60640
- Uptown Research Institute, LLC
-
Edwardsville、Illinois、美国、62025
- Cunningham Clinical Research, Llc
-
Hoffman Estates、Illinois、美国、60194
- Comprehensive NeuroScience, Inc.
-
Springfield、Illinois、美国、62711
- Vine Street Clinical Research Center
-
-
Kansas
-
Witchita、Kansas、美国、67211
- Clinical Research Institute
-
-
Louisiana
-
New Orleans、Louisiana、美国、70115
- LSU Health Sciences Center
-
-
Maryland
-
Baltimore、Maryland、美国、21208
- Pharmasite Research, Inc.
-
-
Michigan
-
Farmington Hills、Michigan、美国、48336
- Summit Research Network
-
Flint、Michigan、美国、48507
- Summit Research Network
-
-
Minnesota
-
Minneapolis、Minnesota、美国、55454
- University of Minnesota
-
St. Paul、Minnesota、美国、55101
- Regions Hospital
-
-
Nevada
-
Las Vegas、Nevada、美国、89146
- Radiant Research Las Vegas
-
-
North Carolina
-
Charlotte、North Carolina、美国、28211
- Behavioral Health Center
-
-
Ohio
-
Dayton、Ohio、美国、45408
- Midwest Clinical Research Center
-
-
Oklahoma
-
Oklahoma City、Oklahoma、美国、73104
- Phebe Tucker, Md
-
-
Oregon
-
Portland、Oregon、美国、97210
- Summit Research Network
-
-
Pennsylvania
-
Media、Pennsylvania、美国、19063
- Suburban Research Associates
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
-
Philadelphia、Pennsylvania、美国、19107
- Thomas Jefferson University
-
-
South Carolina
-
Charleston、South Carolina、美国、29407
- Southeast Health Consultants
-
Columbia、South Carolina、美国、29203
- Usc School Of Medicine
-
-
Texas
-
Austin、Texas、美国、78754
- Community Clinical Research, Inc.
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- University Of Utah School Of Medicine
-
Salt Lake City、Utah、美国、84107
- Radiant Research, Slc
-
-
Virginia
-
Charlottesville、Virginia、美国、22903
- University of Virginia
-
-
Washington
-
Bellevue、Washington、美国、98004
- Northwest Clinical Research Center
-
-
Wisconsin
-
Brown Deer、Wisconsin、美国、53223
- Northbrooke Research Center
-
Middleton、Wisconsin、美国、53562
- Dean Foundation For Health Research & Education
-
-
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:
- Men and women, 18-65 years old who have experienced single or recurrent, non-psychotic episodes of Major Depressive Disorder, with the current episode of minimally 8 weeks in duration.
- Treatment history of an inadequate response to at least one and no more than three adequate antidepressant trials.
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：诊断
- 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 |
|---|---|
|
实验性的：A1
|
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
其他名称：
|
|
安慰剂比较：A2
|
Tablets, Oral, 2 - 20 mg variable dose once daily, 14 weeks
|
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 |
|---|---|---|
|
Mean Change in the Montgomery Åsberg Depression Rating Scale (MADRS)
大体时间：Baseline (Week 8) and Week 14
|
Mean change from Week 8 (baseline) to Week 14 in MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).
Change from baseline=postbaseline score - baseline score.
A negative change score indicates improvement.
|
Baseline (Week 8) and Week 14
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change in Sheehan Disability Scale (SDS) Mean Score
大体时间：Baseline (Week 8) and Week 14
|
Mean change from Week 8 (baseline) to Week 14 in SDS Mean Score, a 3-item, ordinal scale (0=unimpaired; 30=highly impaired).
Change from baseline=postbaseline score - baseline score.
A negative change score indicates improvement.
|
Baseline (Week 8) and Week 14
|
|
Mean Change in SDS Item Score (Social Life)
大体时间：Baseline (Week 8) and Week 14
|
Mean change from Week 8 (baseline) to Week 14 in SDS Social Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired).
Change from baseline=postbaseline score - baseline score.
A negative change score indicates improvement.
|
Baseline (Week 8) and Week 14
|
|
Mean Change in SDS Item Score (Family Life)
大体时间：Baseline (Week 8) and Week 14
|
Mean change from Week 8 (Baseline) to Week 14 in SDS Family Life Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired).
Change from baseline=postbaseline score - baseline score.
A negative change score indicates improvement.
|
Baseline (Week 8) and Week 14
|
|
Mean Change in SDS Item Score (Work/School)
大体时间：Baseline (Week 8) and Week 14
|
Mean change from Week 8 (baseline) to Week 14 in SDS Work/School Item Score, 1 item from a 3-item, ordinal scale (0=unimpaired; 10=highly impaired).
Change from baseline=postbaseline score - baseline score.
A negative change score indicates improvement.
|
Baseline (Week 8) and Week 14
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
MADRS Response
大体时间：Baseline (Week 8) and Week 14
|
Number of subjects with a ≥50 percent reduction from Week 8 (baseline) in MADRS Total Score, a 10-item, ordinal rating scale to assess the severity of depressive symptoms (0=no symptoms; 60=most severe symptoms).
|
Baseline (Week 8) and Week 14
|
|
Clinical Global Impression (CGI)-Improvement Response
大体时间：Baseline (Week 8) and Week 14
|
Number of subjects with response relative to Week 8 (baseline).
Response defined as score of 1 (very much improved) or 2 (much improved) on a 7-point, ordinal scale (1=very much improved; 7=very much worse).
|
Baseline (Week 8) and Week 14
|
|
MADRS Remission
大体时间：Baseline (Week 8) and Week 14
|
Number of subjects in remission.
Remission defined as as MADRS Total Score of <10 at 14 weeks, and a reduction of ≥50 percent from Week 8 (baseline) in MADRS, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms).
|
Baseline (Week 8) and Week 14
|
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。
一般刊物
- Berman RM, Fava M, Thase ME, Trivedi MH, Swanink R, McQuade RD, Carson WH, Adson D, Taylor L, Hazel J, Marcus RN. Aripiprazole augmentation in major depressive disorder: a double-blind, placebo-controlled study in patients with inadequate response to antidepressants. CNS Spectr. 2009 Apr;14(4):197-206. doi: 10.1017/s1092852900020216.
- Stewart TD, Hatch A, Largay K, Sheehan JJ, Marler SV, Berman RM, Nelson JC. Effect of symptom severity on efficacy and safety of aripiprazole adjunctive to antidepressant monotherapy in major depressive disorder: a pooled analysis. J Affect Disord. 2014 Jun;162:20-5. doi: 10.1016/j.jad.2014.03.017. Epub 2014 Mar 24.
- Casey DE, Laubmeier KK, Marler SV, Forbes RA, Baker RA. Efficacy of adjunctive aripiprazole in major depressive disorder: a pooled response quartile analysis and the predictive value of week 2 early response. Prim Care Companion CNS Disord. 2012;14(3):PCC.11m01251. doi: 10.4088/PCC.11m01251. Epub 2012 May 31.
- Fabian TJ, Cain ZJ, Ammerman D, Eudicone JM, Tang Y, Rollin LM, Forbes RA, Berman RM, Baker RA. Improvement in functional outcomes with adjunctive aripiprazole versus placebo in major depressive disorder: a pooled post hoc analysis of 3 short-term studies. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01394. doi: 10.4088/PCC.12m01394. Epub 2012 Dec 20.
- Dunner DL, Laubmeier KK, Manos G, Forbes RA, Baker RA, Berman RM. Beneficial effects of adjunctive aripiprazole in major depressive disorder are not dependent on antidepressant therapy history: a post hoc analysis of 3 randomized, double-blind, placebo-controlled trials. Prim Care Companion CNS Disord. 2012;14(6):PCC.12m01380. doi: 10.4088/PCC.12m01380. Epub 2012 Nov 22.
- Fava M, Dording CM, Baker RA, Mankoski R, Tran QV, Forbes RA, Eudicone JM, Owen R, Berman RM. Effects of adjunctive aripiprazole on sexual functioning in patients with major depressive disorder and an inadequate response to standard antidepressant monotherapy: a post hoc analysis of 3 randomized, double-blind, placebo-controlled studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m00994. doi: 10.4088/PCC.10m00994gre.
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
2005年3月1日
初级完成 (实际的)
2008年3月1日
研究完成 (实际的)
2008年3月1日
研究注册日期
首次提交
2005年3月9日
首先提交符合 QC 标准的
2005年3月9日
首次发布 (估计)
2005年3月10日
研究记录更新
最后更新发布 (估计)
2013年12月2日
上次提交的符合 QC 标准的更新
2013年11月7日
最后验证
2011年4月1日
更多信息
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.
严重抑郁症的临床试验
-
Hospital Universitari Vall d'Hebron Research InstituteInstituto de Salud Carlos III完全的
-
Dren BioNovotech招聘中侵袭性 NK 细胞白血病 | 肝脾T细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 单形性趋上皮性肠 T 细胞淋巴瘤 | LGLL - 大颗粒淋巴细胞白血病 | 原发性皮肤 T 细胞淋巴瘤 - 类别 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | 系统性 EBV1 T 细胞淋巴瘤，如果 CD8 阳性 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | 结外 NK/T 细胞淋巴瘤，鼻型 | 胃肠道惰性慢性淋巴增生性疾病 (CLPD)（CD8+ 或 NK 衍生） | 上面未列出的其他 CD8+/NK 细胞驱动的淋巴瘤美国, 澳大利亚, 法国, 西班牙
-
Memorial Sloan Kettering Cancer Center招聘中蕈样肉芽肿 | 塞扎里综合症 | 血管免疫母细胞性T细胞淋巴瘤 | 肝脾T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阳性 | 结外 NK/T 细胞淋巴瘤，鼻型 | T细胞淋巴瘤 | 未特指的外周 T 细胞淋巴瘤 | 原发性皮肤间变性大细胞淋巴瘤 | 皮下脂膜炎样 T 细胞淋巴瘤 | 肠病相关的T细胞淋巴瘤 | 间变性大细胞淋巴瘤，ALK 阴性 | 单形性趋上皮性肠 T 细胞淋巴瘤 | T 细胞幼淋巴细胞白血病 | T 细胞大颗粒淋巴细胞白血病 | 原发性皮肤 CD8 阳性侵袭性嗜表皮 T 细胞淋巴瘤 | Hydroa Vacciniforme-Like Lymphoproliferative Disorder | NK细胞淋巴瘤 | 侵袭性 NK 细胞白血病 | 成人 T 细胞白血病/淋巴瘤 及其他条件美国
Aripiprazole+ ADT的临床试验
-
Otsuka Pharmaceutical Development & Commercialization...完全的精神错乱 | 抑郁症 | 沮丧 | 情绪障碍 | 抑郁症，主要美国, 俄罗斯联邦, 匈牙利, 罗马尼亚, 乌克兰, 加拿大, 德国
-
Otsuka Pharmaceutical Development & Commercialization...完全的精神错乱 | 抑郁症 | 沮丧 | 情绪障碍 | 抑郁症，主要美国, 法国, 波兰, 加拿大, 斯洛伐克
-
Peking University First HospitalThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; Xijing Hospital...招聘中
-
VZW Cardiovascular Research Center AalstAZ Sint-Jan AV未知
-
Otsuka Pharmaceutical Development & Commercialization...完全的
-
San Diego State UniversityNational Institute of Mental Health (NIMH)完全的