A Phase 4 12-week, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating The Safety And Efficacy Of Varenicline Tartrate (CP-526,555) 1mg BID For Smoking Cessation In Subjects With Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 525
- 试验地点
- 38
- 主要终点
- Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
研究概览
简要总结
Patients with depression tend to have a higher prevalence of smoking as well as increased severity of nicotine dependence. Phase 2 and Phase 3 varenicline clinical trials that demonstrated its efficacy and tolerability have not included subjects with depression. This smoking cessation study focuses on the depressed population and will assess the efficacy and safety of varenicline.
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
- Double (Participant, Investigator)
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
- •Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt
- •Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening
- •Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following:
- •On stable antidepressant treatment for MDD (stable dose for at least 2 months)
- •Major depressive episode, using DSM IV TR, in the past 2 years successfully treated
排除标准
- •Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder.
- •Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements..
- •Current use of either bupropion or nortryptiline.
研究组 & 干预措施
varenicline
干预措施: varenicline (Drug)
placebo
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
时间窗: Week 9 through Week 12
Percentage of participants who reported no use of nicotine-containing products by answering "No" to the nicotine use inventory (NUI) questions: 'Has the participant smoked cigarettes' and 'Has the participant used other nicotine-containing products' in the last 7 days (Week 9) or since last study visit (Week 9 through 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide (CO) measurement less than or equal to 10 parts per million (ppm).
次要结局
- Number of Participants With 4-Week Point Prevalence (PP) of Abstinence(Week 52)
- Percentage of Participants With Continuous Abstinence Rate (CAR)(Week 9 through Week 24, Week 9 through Week 52)
- Number of Participants With 7-day Point Prevalence (PP) of Abstinence(Weeks 12, 24, 52)