A 10-Month Open-Label Evaluation Of The Long-Term Safety Of Desvenlafaxine Succinate Sustained Release In Japanese Adults 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
- 304
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety of desvenlafaxine succinate sustained release tablets during 10-month open-label treatment of Japanese subjects with major depressive disorder (MDD).
The secondary objective is to evaluate the long-term response of subjects receiving desvenlafaxine succinate sustained release tablets by clinical global evaluation, general well-being and absence of symptoms.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who have completed double-blind therapy in short-term study for the indication of major depressive disorder (MDD), including scheduled evaluations, with no major protocol violations and no study events that, in the opinion of the investigator, would preclude the subject's entry into the long-term, open-label study.
排除标准
- •Clinically important abnormalities on baseline (day 56 of the short-term study) physical examination, or any unresolved clinically significant abnormalities on electrocardiogram (ECG), laboratory test results, or vital signs recorded before day 56 in the previous short-term study for the indication of MDD.
研究组 & 干预措施
1
DVS SR
干预措施: desvenlafaxine succinate sustained release tablets (Drug)
结局指标
主要结局
Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score
时间窗: Baseline (Extension Study) up to Day 308 or Final On-Therapy (FOT) Evaluation
HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3-point (0 to 2) or a 5-point scale (0 to 4) with 0=none/absent and 4=most severe, for a maximum total score of 50. Higher scores indicate greater severity. FOT evaluation is defined as the last "on-therapy" evaluation, regardless of the number of days on therapy. Analysis on Observed cases (non-missing data) and Last observation carried forward (LOCF); LOCF method of imputation for any missing value at any visit.
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline (Extension Study) up to Day 329 or 15 days after last dose of study treatment
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be an SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
次要结局
- Number of Participants With Categorical Scores on Clinical Global Impression-Improvement (CGI-I)(Day 308 or FOT Evaluation)
- Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score(Baseline (Extension Study) up to Day 308 or FOT Evaluation)