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Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression

2013年3月6日 更新者：Pfizer

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

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

525

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、107076
        • Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
      • Moscow、俄罗斯联邦、115522
        • Institution of Russian Academy of Medical Sciences Mental Health Research Center
      • Moscow、俄罗斯联邦、125367
        • Moscow State Healthcare Institution Clinical Mental Hospital No 12
      • St-Petersburg、俄罗斯联邦、190121
        • St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
  • 克罗地亚
      • Zagreb、克罗地亚、10000
        • "Poliklinika Neuron" - Croatian Institute for Brain Research
      • Zagreb、克罗地亚、10000
        • Psychiatric Hospital Vrapce
  • 匈牙利
      • Budapest、匈牙利、1137
        • Processus Kft., Varoskapu Rendelo
      • Budapest、匈牙利、1135
        • Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
      • Gyula、匈牙利、5700
        • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
      • Kunszentmarton、匈牙利、5440
        • Varosi Egeszsegugyi Kozpont
      • Szekesfehervar、匈牙利、8000
        • Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
      • Szentes、匈牙利、6600
        • Donatella 99 Bt.
  • 德国
      • Freiburg、德国、79104
        • Universitaetsklinikum Freiburg
      • Muenchen、德国、80336
        • Ludwig Maximilians-Universitaet Muenchen
      • Tuebingen、德国、72076
        • Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
  • 波斯尼亚和黑塞哥维那
      • Banja Luka、波斯尼亚和黑塞哥维那、78000
        • Psychiatric Clinic, Clinical Center Banja Luka
      • Sarajevo、波斯尼亚和黑塞哥维那、71000
        • Clinic of Psychiatry, Clinical Center University of Sarajevo
  • 罗马尼亚
      • Bucuresti、罗马尼亚、041902
        • Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
      • Iasi、罗马尼亚、700282
        • Spitalul Clinic de Psihiatrie Socola, sectia VII
    • Sector 4
      • Bucuresti、Sector 4、罗马尼亚
        • Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
  • 美国
    • California
      • Garden Grove、California、美国、92845
        • Collaborative Neuroscience Network, Inc.
      • Sherman Oaks、California、美国、91403
        • California Neuroscience Research Medical Group, Inc
    • Colorado
      • Aurora、Colorado、美国、80045
        • Behavioral Health and Wellness Program, University of Colorado Denver
    • Connecticut
      • Norwich、Connecticut、美国、06360
        • Comprehensive Psychiatric Care
    • Florida
      • Fort Walton Beach、Florida、美国、32547
        • Emerald Coast Mood & Memory, PA
      • Jacksonville、Florida、美国、32216
        • Clinical Neuroscience Solutions Incorporated
      • Orlando、Florida、美国、32806
        • Clinical Neuroscience Solutions Incorporated
    • Kansas
      • Overland、Kansas、美国、66211
        • Vince and Associates Clinical Research
      • Overland Park、Kansas、美国、66212
        • Vince and Associates Clinical Research
      • Wichita、Kansas、美国、67207
        • Heartland Research Associates, LLC
    • Ohio
      • Beachwood、Ohio、美国、44122
        • NorthCoast Clinical Trials Inc.
      • Cincinnati、Ohio、美国、45219
        • University of Cincinnati
      • Cincinnati、Ohio、美国、45237
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19139
        • CRI Worldwide LLC
    • Tennessee
      • Bartlett、Tennessee、美国、38134
        • Clinical Trials of Memphis
    • Texas
      • Austin、Texas、美国、78731
        • FutureSearch Trials
      • Houston、Texas、美国、77008
        • Claghorn-Lesem Research Clinic, Ltd.
  • 西班牙
      • Barcelona、西班牙、08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona、西班牙、08035
        • Hospital General de La Vall D'Hebron
      • Zaragoza、西班牙、50007
        • Centro de Salud Torrero La Paz
    • Asturias
      • Oviedo、Asturias、西班牙、33011
        • Centro de Salud Mental Ii "La Corredoria"

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：placebo
placebo tablets matched in appearance and dosage to varenicline tablets
实验性的：伐尼克兰
药品：varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
其他名称：
  • Champix/Chantix

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
大体时间：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).
Week 9 through Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Continuous Abstinence Rate (CAR)
大体时间：Week 9 through Week 24, Week 9 through Week 52
Percentage of participants who remained abstinent from the period defined as start of the primary endpoint (Week 9) through Week 24 and the end of follow-up (Week 52) by reporting no use of nicotine-containing products confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Week 9 through Week 24, Week 9 through Week 52
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
大体时间：Weeks 12, 24, 52
Number of participants reporting no use of nicotine-containing products in the last 7 days confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Weeks 12, 24, 52
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
大体时间：Week 52
Number of participants at Week 52 visit reporting no smoking and no use of other tobacco products in the last 4 weeks confirmed by a measurement of an end-expiratory exhaled CO measurement less than or equal to 10 ppm.
Week 52

其他结果措施

结果测量
措施说明
大体时间
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
大体时间：Baseline up to Week 16
Adverse Event (AE):any untoward medical occurrence attributed to study drug in participant who received study drug.SAE:AE causing:death;initial/prolonged inpatient hospitalization;life-threatening experience(immediate risk of dying);persistent/significant disability/incapacity;congenital anomaly.Solicited AEs collected by semi-structured neuropsychiatric AEs interview inquiring about AEs:delusions,hallucinations,paranoia,psychosis,mania,panic,agitation,hostility,aggression,homicidal ideation. If participant had positive response,investigator determined if it met AE criteria.
Baseline up to Week 16
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
大体时间：Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement from baseline is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Change: mean score at observation minus mean score at baseline.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
HAM-A measures treatment-related changes in generalized anxiety symptoms; 14 item questionnaire scored 0 (not present) to 4 (very severe); possible range 0 to 56. Lower score indicates less affected. Change: mean score at observation minus mean score at baseline.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
大体时间：Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
The BIS-11 is a self-administered 30 items questionnaire to assess measure of impulsivity. Items are scored on a 4-point scale ranging from 1 (rarely/never) to 4 (almost always/always). Total score range from 30 to 120. Barratt suggested that a total score of greater than or equal to 75 could indicate an impulse-control disorder, whereas a total score in the range of 70 to 75 could indicate pathological impulsivity.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
大体时间：Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
C-SSRS assessed if participant experienced following: completed suicide (1), suicide attempt (2)(response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4)("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年3月1日

初级完成 (实际的)

2012年6月1日

研究完成 (实际的)

2012年6月1日

研究注册日期

首次提交

2010年2月26日

首先提交符合 QC 标准的

2010年2月26日

首次发布 (估计)

2010年3月2日

研究记录更新

最后更新发布 (估计)

2013年4月16日

上次提交的符合 QC 标准的更新

2013年3月6日

最后验证

2013年3月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A3051122

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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