Back to resultsSafety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Primary Purpose
Smoking Cessation, Depression
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
varenicline
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Smoking Cessation focused on measuring smoking, smoking cessation, smoking cessation in depressed subjects
Eligibility Criteria
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.
Sites / Locations
- Collaborative Neuroscience Network, Inc.
- California Neuroscience Research Medical Group, Inc
- Behavioral Health and Wellness Program, University of Colorado Denver
- Comprehensive Psychiatric Care
- Emerald Coast Mood & Memory, PA
- Clinical Neuroscience Solutions Incorporated
- Clinical Neuroscience Solutions Incorporated
- Vince and Associates Clinical Research
- Vince and Associates Clinical Research
- Heartland Research Associates, LLC
- NorthCoast Clinical Trials Inc.
- University of Cincinnati
- University of Cincinnati
- CRI Worldwide LLC
- Clinical Trials of Memphis
- FutureSearch Trials
- Claghorn-Lesem Research Clinic, Ltd.
- Psychiatric Clinic, Clinical Center Banja Luka
- Clinic of Psychiatry, Clinical Center University of Sarajevo
- "Poliklinika Neuron" - Croatian Institute for Brain Research
- Psychiatric Hospital Vrapce
- Universitaetsklinikum Freiburg
- Ludwig Maximilians-Universitaet Muenchen
- Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
- Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
- Processus Kft., Varoskapu Rendelo
- Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
- Varosi Egeszsegugyi Kozpont
- Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
- Donatella 99 Bt.
- Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
- Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
- Spitalul Clinic de Psihiatrie Socola, sectia VII
- Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
- Institution of Russian Academy of Medical Sciences Mental Health Research Center
- Moscow State Healthcare Institution Clinical Mental Hospital No 12
- St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
- Centro de Salud Mental Ii "La Corredoria"
- Hospital de La Santa Creu I Sant Pau
- Hospital General de La Vall D'Hebron
- Centro de Salud Torrero La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
varenicline
placebo
Arm Description
placebo
Outcomes
Primary Outcome Measures
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
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).
Secondary Outcome Measures
Percentage of Participants With Continuous Abstinence Rate (CAR)
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.
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
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.
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01078298
Brief Title
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Depression
Keywords
smoking, smoking cessation, smoking cessation in depressed subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
525 (Actual)
8. Arms, Groups, and Interventions
Arm Title
varenicline
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Champix/Chantix
Intervention Description
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablets matched in appearance and dosage to varenicline tablets
Primary Outcome Measure Information:
Title
Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
Description
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).
Time Frame
Week 9 through Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Continuous Abstinence Rate (CAR)
Description
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.
Time Frame
Week 9 through Week 24, Week 9 through Week 52
Title
Number of Participants With 7-day Point Prevalence (PP) of Abstinence
Description
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.
Time Frame
Weeks 12, 24, 52
Title
Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
Description
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.
Time Frame
Week 52
Other Pre-specified Outcome Measures:
Title
Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
Description
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.
Time Frame
Baseline up to Week 16
Title
Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
Description
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
Time Frame
Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Title
Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
Description
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
Time Frame
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Description
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.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Title
Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
Description
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.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Title
Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
Description
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.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
Title
Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description
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").
Time Frame
Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Behavioral Health and Wellness Program, University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Emerald Coast Mood & Memory, PA
City
Fort Walton Beach
State/Province
Florida
ZIP/Postal Code
32547
Country
United States
Facility Name
Clinical Neuroscience Solutions Incorporated
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions Incorporated
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
NorthCoast Clinical Trials Inc.
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45237
Country
United States
Facility Name
CRI Worldwide LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Clinical Trials of Memphis
City
Bartlett
State/Province
Tennessee
ZIP/Postal Code
38134
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Psychiatric Clinic, Clinical Center Banja Luka
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
Clinic of Psychiatry, Clinical Center University of Sarajevo
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
"Poliklinika Neuron" - Croatian Institute for Brain Research
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Psychiatric Hospital Vrapce
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Universitaetsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79104
Country
Germany
Facility Name
Ludwig Maximilians-Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Processus Kft., Varoskapu Rendelo
City
Budapest
ZIP/Postal Code
1137
Country
Hungary
Facility Name
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Varosi Egeszsegugyi Kozpont
City
Kunszentmarton
ZIP/Postal Code
5440
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Donatella 99 Bt.
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
City
Bucuresti
State/Province
Sector 4
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
City
Bucuresti
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie Socola, sectia VII
City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
City
Moscow
ZIP/Postal Code
107076
Country
Russian Federation
Facility Name
Institution of Russian Academy of Medical Sciences Mental Health Research Center
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Facility Name
Moscow State Healthcare Institution Clinical Mental Hospital No 12
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
City
St-Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Facility Name
Centro de Salud Mental Ii "La Corredoria"
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital General de La Vall D'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Centro de Salud Torrero La Paz
City
Zaragoza
ZIP/Postal Code
50007
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
24042367
Citation
Anthenelli RM, Morris C, Ramey TS, Dubrava SJ, Tsilkos K, Russ C, Yunis C. Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Intern Med. 2013 Sep 17;159(6):390-400. doi: 10.7326/0003-4819-159-6-201309170-00005. Erratum In: Ann Intern Med. 2013 Oct 15;159(8):576.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051122&StudyName=Safety%20And%20Efficacy%20Of%2012%20Weeks%20Of%20Varenicline%20For%20Smoking%20Cessation%20In%20Smokers%20With%20Depression%20%20
Description
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Learn more about this trial
Safety And Efficacy Of 12 Weeks Of Varenicline For Smoking Cessation In Smokers With Depression
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