A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Evaluate The Efficacy, Safety And Tolerability Of Desvenlafaxine Succinate Sustained-release (Dvs Sr) In The Treatment Of Children And Adolescent Outpatients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 363
- 试验地点
- 42
- 主要终点
- Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
研究概览
简要总结
This is a double-blind study evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) versus placebo in the Treatment of Children and Adolescent Outpatients with Major Depressive Disorder (MDD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Age >=7 and <18 years of age
- •Primary diagnosis of major depressive disorder (MDD)
- •CDRS-R score >40
排除标准
- •History of suicidal behavior or requires precaution against suicide
- •Not in generally healthy medical condition
- •History of psychosis or bipolar disorder
- •Seizure disorder
研究组 & 干预措施
Experimental Arm 1 - high dose
干预措施: Desvenlafaxine Succinate Sustained-Release (Drug)
Experimental Arm 2 - low dose
干预措施: Desvenlafaxine Succinate Sustained-Release (Drug)
Placebo Arm
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score (n=102, 104, 106)
时间窗: Baseline and Week 8
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Mean change from baseline was adjusted for the baseline total score, age group and gender.
次要结局
- Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score (n=102, 105, 106)(Baseline and Week 8)
- Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8(Weeks 1, 2, 3, 4, 6, and 8)
- Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'(Weeks 1, 2, 3, 4, 6, and 8)