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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01078298
• Other study ID #: A3051122
• Status: Completed
• Phase: Phase 4
• First received: February 26, 2010
• Last updated: March 6, 2013
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Smoking Cessation

Intervention

Drug:
• varenicline
varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
• placebo
placebo tablets matched in appearance and dosage to varenicline tablets

Locations

Country	Name	City	State
Bosnia and Herzegovina	Psychiatric Clinic, Clinical Center Banja Luka	Banja Luka
Bosnia and Herzegovina	Clinic of Psychiatry, Clinical Center University of Sarajevo	Sarajevo
Croatia	"Poliklinika Neuron" - Croatian Institute for Brain Research	Zagreb
Croatia	Psychiatric Hospital Vrapce	Zagreb
Germany	Universitaetsklinikum Freiburg	Freiburg
Germany	Ludwig Maximilians-Universitaet Muenchen	Muenchen
Germany	Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie	Tuebingen
Hungary	Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly	Budapest
Hungary	Processus Kft., Varoskapu Rendelo	Budapest
Hungary	Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly	Gyula
Hungary	Varosi Egeszsegugyi Kozpont	Kunszentmarton
Hungary	Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly	Szekesfehervar
Hungary	Donatella 99 Bt.	Szentes
Romania	Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2	Bucuresti
Romania	Spitalul Psihiatrie "Prof. Dr. Al. Obregia"	Bucuresti	Sector 4
Romania	Spitalul Clinic de Psihiatrie Socola, sectia VII	Iasi
Russian Federation	Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav	Moscow
Russian Federation	Institution of Russian Academy of Medical Sciences Mental Health Research Center	Moscow
Russian Federation	Moscow State Healthcare Institution Clinical Mental Hospital No 12	Moscow
Russian Federation	St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital	St-Petersburg
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General de La Vall D'Hebron	Barcelona
Spain	Centro de Salud Mental Ii "La Corredoria"	Oviedo	Asturias
Spain	Centro de Salud Torrero La Paz	Zaragoza
United States	Behavioral Health and Wellness Program, University of Colorado Denver	Aurora	Colorado
United States	FutureSearch Trials	Austin	Texas
United States	Clinical Trials of Memphis	Bartlett	Tennessee
United States	NorthCoast Clinical Trials Inc.	Beachwood	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Emerald Coast Mood & Memory, PA	Fort Walton Beach	Florida
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Claghorn-Lesem Research Clinic, Ltd.	Houston	Texas
United States	Clinical Neuroscience Solutions Incorporated	Jacksonville	Florida
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Clinical Neuroscience Solutions Incorporated	Orlando	Florida
United States	Vince and Associates Clinical Research	Overland	Kansas
United States	Vince and Associates Clinical Research	Overland Park	Kansas
United States	CRI Worldwide LLC	Philadelphia	Pennsylvania
United States	California Neuroscience Research Medical Group, Inc	Sherman Oaks	California
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bosnia and Herzegovina,  Croatia,  Germany,  Hungary,  Romania,  Russian Federation,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)	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	Yes
Other	Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)	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	Yes
Other	Number of Participants With Clinical Global Impression - Severity (CGI-S) Score	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	Yes
Other	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score	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	Yes
Other	Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score	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	Yes
Other	Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score	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	Yes
Other	Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	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])	Yes
Primary	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).	Week 9 through Week 12	No
Secondary	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.	Week 9 through Week 24, Week 9 through Week 52	No
Secondary	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.	Weeks 12, 24, 52	No
Secondary	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.	Week 52	No

External Links

•   To obtain contact information for a study center near you, click here.