Clinical trial NCT01078298: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Smoking Cessation
Depression
Keywords: smoking
smoking cessation
smoking cessation in depressed subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-03-02
Enrollment: 525
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Participants With a Four-Week Continuous Quit Rate (CQR)
timeFrame: Week 9 through Week 12
Secondary outcomes:
measure: Percentage of Participants With Continuous Abstinence Rate (CAR)
timeFrame: Week 9 through Week 24, Week 9 through Week 52
measure: Number of Participants With 7-day Point Prevalence (PP) of Abstinence
timeFrame: Weeks 12, 24, 52
measure: Number of Participants With 4-Week Point Prevalence (PP) of Abstinence
timeFrame: Week 52
Other outcomes:
measure: Number of Participants With Adverse Events (Including Solicited Neuropsychiatric Adverse Events)
timeFrame: Baseline up to Week 16
measure: Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I)
timeFrame: Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
measure: Number of Participants With Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16, 24, 32, 40, 52
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) - Total Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
measure: Change From Baseline in Barratt Impulsiveness Scale (BIS-11) - Total Score
timeFrame: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 16
measure: Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Week 1 up to 30 days after Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (follow-up [FU])
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group, Inc
state: California
city: Aurora
country: United States
facility: Behavioral Health and Wellness Program, University of Colorado Denver
state: Colorado
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care
state: Connecticut
city: Fort Walton Beach
country: United States
facility: Emerald Coast Mood & Memory, PA
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Incorporated
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Incorporated
state: Florida
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Overland
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Beachwood
country: United States
facility: NorthCoast Clinical Trials Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide LLC
state: Pennsylvania
city: Bartlett
country: United States
facility: Clinical Trials of Memphis
state: Tennessee
city: Austin
country: United States
facility: FutureSearch Trials
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic, Ltd.
state: Texas
city: Banja Luka
country: Bosnia and Herzegovina
facility: Psychiatric Clinic, Clinical Center Banja Luka
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Psychiatry, Clinical Center University of Sarajevo
city: Zagreb
country: Croatia
facility: "Poliklinika Neuron" - Croatian Institute for Brain Research
city: Zagreb
country: Croatia
facility: Psychiatric Hospital Vrapce
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
city: Muenchen
country: Germany
facility: Ludwig Maximilians-Universitaet Muenchen
city: Tuebingen
country: Germany
facility: Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly
city: Budapest
country: Hungary
facility: Processus Kft., Varoskapu Rendelo
city: Gyula
country: Hungary
facility: Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Pszichiatriai Osztaly
city: Kunszentmarton
country: Hungary
facility: Varosi Egeszsegugyi Kozpont
city: Szekesfehervar
country: Hungary
facility: Fejer Megyei Szent Gyorgy Korhaz, Pszichiatriai Osztaly
city: Szentes
country: Hungary
facility: Donatella 99 Bt.
city: Bucuresti
country: Romania
facility: Spitalul Psihiatrie "Prof. Dr. Al. Obregia"
state: Sector 4
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Al. Obregia, sectia 2
city: Iasi
country: Romania
facility: Spitalul Clinic de Psihiatrie Socola, sectia VII
city: Moscow
country: Russian Federation
facility: Federal State Institution Moscow Scientific Research Institute of Psychiatry of Roszdrav
city: Moscow
country: Russian Federation
facility: Institution of Russian Academy of Medical Sciences Mental Health Research Center
city: Moscow
country: Russian Federation
facility: Moscow State Healthcare Institution Clinical Mental Hospital No 12
city: St-Petersburg
country: Russian Federation
facility: St-Petersburg State Healthcare Institution St. Nicholas Mental Hospital
city: Oviedo
country: Spain
facility: Centro de Salud Mental Ii "La Corredoria"
state: Asturias
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hospital General de La Vall D'Hebron
city: Zaragoza
country: Spain
facility: Centro de Salud Torrero La Paz
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.