Anthenelli 2013.

Study characteristics
Methods	Study design: RCT Country: Bosnia and Herzegovina, Croatia, Germany, Hungary, Romania, Russian Federation, Spain, United States Data collection period: March 2010 – June 2012 Registry ID: ClinicalTrials.gov: NCT01078298
Participants	Number of participants: N = 525 Sample characteristics (at baseline): Age (mean): 45.4 years (SD 10.9) varenicline group, 47.1 years (SD 10.8) placebo group; Sex (% male): 37.3% (196/525) Population category: psychiatric population; Specific population: persons with stably‐treated current or past major depressive disorder (MDD) Nicotine dependence: FTND 5.9 (SD 1.9) varenicline group, 5.9 (SD 2.0) placebo group; Baseline cigarettes per day: 22 cigarettes daily in the past month (varenicline group 21.9 (SD 7.5), placebo group 21.5 (SD 8.7)); Motivation to quit: selected by motivation to quit
Interventions	Behavioural support for smoking cessation: manual‐guided smoking cessation counselling developed by a study author in accordance with Agency for Healthcare Research and Quality guidelines – provided at each clinic and telephone visit from baseline through to week 52 Pharmacological support for smoking cessation: varenicline or placebo Psychotherapeutic or psychoactive support for mental health or mood: received mood management ‐ most participants (varenicline 70.7%, placebo 73.2%) were receiving antidepressant medications at study entry; selective serotonin reuptake inhibitors and serotonin–norepinephrine reuptake inhibitors the predominant choice (varenicline, 61.3%; placebo, 67.7%), other most common psychotropic treatment was alprazolam (varenicline, 8.6%; placebo, 13.4%)
Outcomes	Definition of cessation used: continuous abstinence rates week 9 – 12; self‐reported 7‐day point‐prevalence of abstinence at weeks 12, 24 and 52 Cessation definition used for outcome(s) in this analysis: continuous abstinence Measure of biovalidation: exhaled CO levels (≤ 10 ppm) Definition of people who continued smoking used: ‘non‐quitters’ (exact definition not reported), carbon monoxide levels > 10 ppm Time point(s) at which follow‐up was conducted: baseline, every week during treatment phase and weeks 13, 14, 16, 20, 24, 28, 43, 36, 40, 44, 48 and 52 Outcome category: Depression Outcome measure(s): Montgomery‐Asberg Depression Rating Scale (MADRS)
Funding source	Study was funded by Pfizer. Dr. Anthenelli’s writing of this manuscript was funded, in part, by a Department of Veterans Affairs Merit Review award (NEUA‐003‐08S) and by a National Institute on Alcohol Abuse and Alcoholism grant (AA019720). Dr. Morris was supported, in part, by grants from the University of California, San Francisco, Smoking Cessation Leadership Center and Colorado Department of Public Health and Environment. Drs. Ramey, Tsilkos, Russ, and Yunis and Ms. Dubrava are employees of Pfizer. Editorial support was provided by Abegale Templar, PhD, of Engage Scientific and funded by Pfizer
Author conflicts of interest	Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNumM13‐0777
Notes	Outcome data source: additional data requested, but this was not received by the deadline and we were unable to include it in this version of the review