A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal, Parallel Group Study To Evaluate The Efficacy And Safety Of 50 mg/Day Of DVS SR In Adult 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
- 874
- 试验地点
- 1
- 主要终点
- Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
研究概览
简要总结
The primary purpose of this study is to compare the long-term efficacy and safety of desvenlafaxine succinate sustained release versus placebo in adults with Major Depressive Disorder, using a randomized withdrawal design. Randomized withdrawal means that after receiving desvenlafaxine succinate sustained release for a predetermined period of time, subjects will be selected by chance to either continue receiving the study drug or to be withdrawn from the study drug and receive placebo for the remainder of their participation in the trial. Subjects will not know to which group they have been assigned.
The study consists of an up to 14-day screening period followed by an 8-week open-label period in which subjects will knowingly receive 50 mg/day of desvenlafaxine succinate sustained release. Subjects who do not respond to treatment, demonstrating no significant change in their depressive symptoms, will be withdrawn from participation at the end of this period. Responding subjects will receive an additional 3 months of open-label desvenlafaxine succinate sustained release at the same dose. Subjects with stable response to treatment at the conclusion of this 3 month period will be randomized to either desvenlafaxine succinate sustained release at 50 mg/day or placebo in a blinded manner for an additional 6 months or until symptoms of depression return. Following discontinuation at any point after enrollment in the study, subjects will receive two weeks of follow-up monitoring, including one week of blinded taper with 25 mg/day of desvenlafaxine succinate sustained release treatment for any subjects who have been taking desvenlafaxine succinate sustained release prior to discontinuation. Subjects assigned to placebo will receive a blinded placebo taper. Following taper, subjects will be evaluated for one additional week to monitor safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening)
- •Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20
- •Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4.
排除标准
- •Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores.
- •Past treatment with desvenlafaxine succinate sustained release.
- •Other eligibility criteria also apply.
研究组 & 干预措施
Desvenlafaxine succinate sustained release 50 mg
干预措施: Desvenlafaxine succinate sustained release 50 mg (Drug)
Desvenlafaxine succinate sustained release 50 mg
干预措施: Desvenlafaxine succinate sustained release 25 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Relapse Following Randomization to the Double-blind (DB) Phase: Estimated Probability (Percent) of Relapse at DB Day 185
时间窗: Double-blind phase Baseline (Study Day 140) up to DB Day 185 (Study Day 325)
Time to relapse analyzed using log-rank test; defined as Hamilton Psychiatric Scale for Depression-17 item score ≥16 at any time during DB phase, discontinuation for unsatisfactory response or efficacy (need for additional or alternate treatment for depression, investigator decision to remove participant for efficacy reasons, or failure to return if investigator determined related to efficacy), hospitalization for depression, suicide attempt, or suicide. Participants who relapsed after DB day 185 or completed DB therapy without relapse were considered as censored on DB day 185 (study day 325).
次要结局
- Number of Participants Per Categorical Score for Change From Baseline on Clinical Global Impression-Improvement (CGI-I) Scale(Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322))
- Change From Baseline of Double-blind Phase in World Health Organization (Five-Item) Well-Being Index(Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322))
- Change From Baseline in Clinical Global Impression-Severity of Illness [CGI-S] Score in the Double-blind Phase(Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322))
- Number of Participants With Remission Based on Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score at Double-blind Phase Week 26(Double-blind phase Week 26 (Study Day 322))
- Change From Baseline in Hamilton Psychiatric Scale for Depression-6 Item (HAM-D6) Score in the Double-blind Phase(Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322))
- Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Score in the Double-blind Phase(Double-blind phase Baseline (Study Day 140), Week 14 (Study Day 238), Week 26 (Study Day 322))
- Change From Baseline in Hamilton Psychiatric Scale for Depression-17 Item (HAM-D17) Score in the Double-blind Phase(Double-blind phase Baseline (Study Day 140) up to Week 26 (Study Day 322))