NCT01371708已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 283
- 试验地点
- 36
- 主要终点
- Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Requires precaution against suicide
- •Not in generally healthy medical condition
- •Poor compliance with study drug or study procedures during participation in study B2061032
研究组 & 干预措施
Desvenlafaxine Succinate Sustained-Release
Experimental
干预措施: DVS SR (Drug)
结局指标
主要结局
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE)
时间窗: 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.
Percentage of Participants With a Treatment-emergent Adverse Event (TEAE) (Combination Group)
时间窗: 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.
次要结局
- Change From Baseline to Week 26 in Total Score on the Children's Depression Rating Scale, Revised (CDRS-R), Based on Observed Cases(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)(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(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)(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(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)(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(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)(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(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)(From Week 8 (B2061032)/Day 1 (B2061030) to Week 26 of B2061030)
研究者
研究点 (36)
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