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A 6-Month Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability, And Efficacy Of DVS SR In The Treatment Of Child And Adolescent Outpatients With MDD

2017年6月28日 更新者：Pfizer

A 6-month, Open-label, Multi-center, Flexible Dose Extension Study To The B2061032 Study To Evaluate The Safety, Tolerability And Efficacy Of Desvenlafaxine Succinate Sustained Release (Dvs Sr) Tablets In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder

This is a 6-month, open-label, flexible-dose study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in the Treatment of Child and Adolescent Outpatients with Major Depressive Disorder (MDD).

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

283

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

  • 智利
    • Region Metropolitana
      • Santiago、Region Metropolitana、智利、7500710
        • BioMedica Research Group
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294-0009
        • The University of Alabama at Birmingham, Office of Psychiatric Research
    • Arizona
      • Tucson、Arizona、美国、85719
        • Center for Advanced Improvement
    • California
      • Imperial、California、美国、92251
        • Sun Valley Research Center
    • Colorado
      • Colorado Springs、Colorado、美国、80910
        • MCB Clinical Research Centers
    • Connecticut
      • Hartford、Connecticut、美国、06106
        • Institute of Living/Hartford Hospital
    • Florida
      • Destin、Florida、美国、32541
        • SJS Clinical Research, Inc.
      • Gainesville、Florida、美国、32607
        • Sarkis Clinical Trials
      • Jacksonville、Florida、美国、32256
        • Clinical Neuroscience Solutions
      • Orange City、Florida、美国、32763
        • Medical Research Group of Central Florida
      • Orlando、Florida、美国、32839
        • Millenia Psychiatry & Research, Inc.
      • West Palm Beach、Florida、美国、33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Marietta、Georgia、美国、30060
        • Northwest Behavioral Research Center
    • Illinois
      • Libertyville、Illinois、美国、60048
        • Capstone Clinical Research
      • Naperville、Illinois、美国、60563
        • Baber Research Group
    • Indiana
      • Terre Haute、Indiana、美国、47802
        • Clinco
    • Maryland
      • Baltimore、Maryland、美国、21208
        • Pharmasite Research, Inc
    • Missouri
      • Creve Coeur、Missouri、美国、63141
        • Millennium Psychiatric Associates, LLC
    • Nebraska
      • Lincoln、Nebraska、美国、68526
        • Premier Psychiatric Research Institute, LLC
    • New York
      • Buffalo、New York、美国、14215
        • Erie County Medical Center/State University of New York (SUNY) at Buffalo Affiliate
      • Glen Oaks、New York、美国、11004
        • The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System
      • Mount Kisco、New York、美国、10549
        • Bioscience Research, LLC.
      • Rochester、New York、美国、14618
        • Finger Lakes Clinical Research
      • Stony Brook、New York、美国、11794-8790
        • Stony Brook University Medical Center, Child And Adolescent Psychiatry
    • Ohio
      • Canton、Ohio、美国、44718
        • Neuro-Behavioral Clinical Research, Inc.
      • Cleveland、Ohio、美国、44106
        • Discovery and Wellness Center for Children/University Hospitals Case Medical Center
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • Sooner Clinical Research
    • Tennessee
      • Memphis、Tennessee、美国、38119
        • Research Strategies of Memphis, LLC.
    • Texas
      • Austin、Texas、美国、78731
        • FutureSearch Trials
      • San Antonio、Texas、美国、78229
        • Clinical Trials of Texas, Inc.
      • San Antonio、Texas、美国、78229
        • Clinical Trials of Texas, Inc
    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University
      • Richmond、Virginia、美国、23230
        • Alliance Research Group
      • Richmond、Virginia、美国、23230
        • Allance Research Group
      • Richmond、Virginia、美国、23298
        • Virginia Treatment Center For Children
    • Washington
      • Kirkland、Washington、美国、98033
        • Eastside Therapeutic Resource

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

7年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Completed study B2061032 and who in the investigator's opinion, would benefit from long term treatment with DVS SR
  • Willingness and ability to comply with scheduled visits, treatment plan, and procedures

Exclusion Criteria:

  • Requires precaution against suicide
  • Not in generally healthy medical condition
  • Poor compliance with study drug or study procedures during participation in study B2061032

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：去甲文拉法辛琥珀酸盐缓释
药品：DVS SR
Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator

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
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
A TEAE was defined as an event that was absent before treatment and emerged or worsened during the treatment period.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total scores indicate lower intensity of symptoms. Remission on the CDRS-R was defined as a CDRS-R score <=28. It was recommended that the CDRS-R be performed prior to the Clinical Global Impression assessments. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Change in Score From Baseline to Week 26 on the Clinical Global Impression-Severity (CGI-S) Scale, Based on Observed Cases (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-S, which rates the severity of illness from 1 to 7, and the CGI-Improvement Scale, which assesses improvement in illness since baseline. The CGI-S is a 7-point scale a clinician uses to rate a patient's severity of illness. Scores range from 1 to 7, with 1 indicating "normal, not at all ill" and 7, "among the most extremely ill patients." Higher score on the CGI-S indicates greater severity of illness. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With a Response of Very Much Improved or Much Improved on the Clinical Global Impression-Improvement (CGI-I) Scale at Week 26, Based on Observed Cases (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants by Score on the Clinical Global Impression-Improvement (CGI-I) Scale, Based on Observed Cases (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
The Clinical Global Impression (CGI) Scale is a tool that summarizes all available patient data, including history, symptoms, behavior, and the impact of the symptoms on ability to function. The scale consists of 2 measures: the CGI-Severity scale, which rates the severity of illness from 1 to 7, and the CGI-I scale, which assesses improvement in illness since baseline. The CGI-I is a 7-point scale used a clinician uses to assess improvement in a patient's illness relative to baseline. Scores range from 1 to 7, with 1 representing "very much improved" and 7 representing "very much worse"; a value of 0 meant not assessed. Lower score indicates greater improvement. Response on the CGI-I defined as the CGI-I scores of 1 or 2. Mean change from baseline=score at Week 26 minus score at baseline of study B2061032.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Percentage of Participants With Remission at Week 26, Based on a Score on the Children's Depression Rating Scale, Revised (CDRS-R), <=28 and on Observed Cases (Combination Group)
大体时间：From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030
Remission on the CDRS-R was defined as a CDRS-R score <=28. The CDRS-R consists of 17 items. The total score is the sum of responses to the 17 items and ranges from 17 to 113. Lower total s cores indicate lower intensity of symptoms.
From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030

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

Pfizer

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 (实际的)

2012年2月2日

初级完成 (实际的)

2016年4月22日

研究完成 (实际的)

2016年4月22日

研究注册日期

首次提交

2011年6月9日

首先提交符合 QC 标准的

2011年6月10日

首次发布 (估计)

2011年6月13日

研究记录更新

最后更新发布 (实际的)

2017年7月27日

上次提交的符合 QC 标准的更新

2017年6月28日

最后验证

2017年6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

  • B2061030
  • 3151A6-3344 (其他标识符：Alias Study Number)
  • 2008-001876-67 (EudraCT编号)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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