A 10 Month Open-Label Evaluation Of The Long-Term Safety Of DVS-233 SR In 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
- 1,403
- 试验地点
- 115
- 主要终点
- Number (%) of Subjects Reporting Adverse Events during Treatment
研究概览
简要总结
The study evaluated the long-term safety of Desvenlafaxine Succinate (DVS) Slow Release (SR) during open-label treatment in adult outpatients who had a primary diagnosis of major depressive disorder (MDD). The study also evaluated the long-term response of subjects receiving DVS SR for clinical global evaluation, functionality, general well-being, pain, and absence of depressive symptoms (remission).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（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 a phase 3 DVS-233 SR short-term study for the indication of 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.
- •Sexually active individuals participating in the study must use a medically acceptable form of contraception during the trial and for at least 15 days after the last dose of study drug.
排除标准
- •Clinically important abnormalities on baseline physical examination, or any unresolved clinically significant abnormalities on ECG, laboratory test results, or vital signs recorded in a previous phase 3 DVS-233 SR short-term study for the indication of MDD. Any exception must be discussed with and granted by the sponsor.
- •Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
- •Presence of clinically important hepatic or renal disease or other medical disease that might compromise the study or be detrimental to the subject (eg, clinically important cardiac arrhythmia, uncontrolled diabetes, uncontrolled hypertension, seizure disorder, myocardial infarction, neurologic disorder, acute illness, neoplastic disorder).
研究组 & 干预措施
DVS
干预措施: Desvenlafaxine Succinate (Drug)
结局指标
主要结局
Number (%) of Subjects Reporting Adverse Events during Treatment
时间窗: 10 months
Number (%) of Subjects With Changes in Vital Signs (Blood Pressure, Pulse Rate, Weight) of Potential Clinical Importance
时间窗: 10 months
Number (%) of Subjects With Laboratory Test Results (Hematology, Blood Chemistry, Lipid Profile, Urinalysis) of Potential Clinical Importance
时间窗: 10 months
Number (%) of Subjects With Electrocardiogram Results (Heart Rate, QTc interval) of Potential Clinical Importance
时间窗: 10 months
次要结局
- Change in Hamilton Depression Rating scale - 17 items version - (HAM-D17) mean score from baseline(10 months)
- Change in Montgomery Asberg Depression Rating Scale (MADRS)mean score from baseline(10 months)
- Change in Clinical Global Improvement Scale-Severity (CGI-S)mean score from baseline(10 months)