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

2013년 3월 6일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

525

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: 위약
의약품: placebo
placebo tablets matched in appearance and dosage to varenicline tablets
실험적: 바레니클린
의약품: varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
다른 이름들:
  • Champix/Chantix

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants With Continuous Abstinence Rate (CAR)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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])

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2010년 3월 1일

기본 완료 (실제)

2012년 6월 1일

연구 완료 (실제)

2012년 6월 1일

연구 등록 날짜

최초 제출

2010년 2월 26일

QC 기준을 충족하는 최초 제출

2010년 2월 26일

처음 게시됨 (추정)

2010년 3월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2013년 4월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2013년 3월 6일

마지막으로 확인됨

2013년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A3051122

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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