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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01078298
Recruitment Status : Completed
First Posted : March 2, 2010
Results First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Depression Drug: varenicline Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 525 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: varenicline Drug: varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
Other Name: Champix/Chantix

Placebo Comparator: placebo
Drug: placebo
placebo tablets matched in appearance and dosage to varenicline tablets

Primary Outcome Measures :
  1. Percentage of Participants With a Four-Week Continuous Quit Rate (CQR) [ Time Frame: 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).

Secondary Outcome Measures :
  1. Percentage of Participants With Continuous Abstinence Rate (CAR) [ Time Frame: 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.

  2. Number of Participants With 7-day Point Prevalence (PP) of Abstinence [ Time Frame: 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.

  3. Number of Participants With 4-Week Point Prevalence (PP) of Abstinence [ Time Frame: 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.

Other Outcome Measures:
  1. Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events) [ Time Frame: 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.

  2. Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) [ Time Frame: 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

  3. Number of Participants With Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: 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

  4. Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score [ Time Frame: 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.

  5. Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score [ Time Frame: 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.

  6. Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score [ Time Frame: 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.

  7. Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 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").

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01078298

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pfizer Identifier: NCT01078298     History of Changes
Other Study ID Numbers: A3051122
First Posted: March 2, 2010    Key Record Dates
Results First Posted: April 16, 2013
Last Update Posted: April 16, 2013
Last Verified: March 2013
Keywords provided by Pfizer:
smoking cessation
smoking cessation in depressed subjects
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs