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