NCT01371721已完成3 期
A 6 Month, Open Label, Multi Center, Flexible Dose Extension Study To The B2061014 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
- 269
- 试验地点
- 34
- 主要终点
- Percentage of Participants Experiencing a Treatment Emergent Adverse Event
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
- 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 B2061014 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
- •Subject requires precaution against suicide
- •Subject not in a generally healthy condition
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 Experiencing a Treatment Emergent Adverse Event
时间窗: Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study
次要结局
- Percentage of Participants With Remission as Determined by a CDRS-R Score of ≤28 at Week 26 Based on Observed Cases(Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
- Change From Baseline at Week 26 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score Based on Observed Cases(Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
- Change From Baseline at Week 26 in the Clinical Global Impression of Severity (CGI-S) Score Based on Observed Cases(Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
- Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Week 26 Based on Observed Cases(Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
- Percentage of Participants With a Clinical Global Impression, Improvement (CGI-I) Response Defined as a Score of 'Very Much Improved' or 'Much Improved' at Week 26(Week 9 (B2061014)/Day 1 (B2061031) to Week 26 of the B2061031 Study)
研究者
研究点 (34)
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