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

• Smoking Cessation
• Depression

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

• Experimental: varenicline
  
  Intervention: Drug: varenicline
• Placebo Comparator: placebo
  
  placebo
  Intervention: Drug: placebo

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.