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

Completed · Phase 4 · Has a placebo group

Conditions studied: Smoking Cessation, Depression

In brief

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.

Key facts

Study ID

NCT01078298

Run by

Pfizer

People needed

525

Starts

2010-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-04-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• California Neuroscience Research Medical Group, Inc — Sherman Oaks, California, United States
• Behavioral Health and Wellness Program, University of Colorado Denver — Aurora, Colorado, United States
• Comprehensive Psychiatric Care — Norwich, Connecticut, United States
• Emerald Coast Mood & Memory, PA — Fort Walton Beach, Florida, United States
• Clinical Neuroscience Solutions Incorporated — Jacksonville, Florida, United States
• Clinical Neuroscience Solutions Incorporated — Orlando, Florida, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Vince and Associates Clinical Research — Overland, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• NorthCoast Clinical Trials Inc. — Beachwood, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• CRI Worldwide LLC — Philadelphia, Pennsylvania, United States
• Clinical Trials of Memphis — Bartlett, Tennessee, United States
• FutureSearch Trials — Austin, Texas, United States
• Claghorn-Lesem Research Clinic, Ltd. — Houston, Texas, United States
• Psychiatric Clinic, Clinical Center Banja Luka — Banja Luka, Bosnia and Herzegovina
• Clinic of Psychiatry, Clinical Center University of Sarajevo — Sarajevo, Bosnia and Herzegovina
• "Poliklinika Neuron" - Croatian Institute for Brain Research — Zagreb, Croatia
• Psychiatric Hospital Vrapce — Zagreb, Croatia
• Universitaetsklinikum Freiburg — Freiburg im Breisgau, Germany
• Ludwig Maximilians-Universitaet Muenchen — München, Germany
• Universitaetsklinik Tuebingen, Klinik fuer Psychiatrie und Psychotherapie — Tübingen, Germany
• Fovarosi Onkormanyzat Nyiro Gyula Korhaz, II. Pszichiatriai Osztaly — Budapest, Hungary

Full record on ClinicalTrials.gov

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