title: Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial.
abstract: Chinese translation
  
  
  BACKGROUND
  Depression is overrepresented in smokers.
  
  
  OBJECTIVE
  To evaluate smoking abstinence and changes in mood and anxiety levels in smokers with depression treated with varenicline versus placebo.
  
  
  METHODS
  Phase 4, multicenter, parallel, 1:1 allocation, double-blind, randomization trial. Randomization, stratified by antidepressant use and depression score at baseline, was blocked in sizes of 4. (ClinicalTrials.gov: NCT01078298).
  
  
  METHODS
  38 centers in 8 countries.
  
  
  METHODS
  525 adult smokers with stably treated current or past major depression and no recent cardiovascular events.
  
  
  METHODS
  Varenicline, 1 mg twice daily, or placebo for 12 weeks, with 40-week nontreatment follow-up.
  
  
  METHODS
  Primary outcome was carbon monoxide-confirmed continuous abstinence rate (CAR) for weeks 9 to 12. Other outcomes included CARs assessed during nontreatment follow-up and ratings of mood, anxiety, and suicidal ideation or behavior.
  
  
  RESULTS
  68.4% versus 66.5% of the varenicline and placebo groups, respectively, completed the study. Varenicline-treated participants had higher CARs versus placebo at weeks 9 to 12 (35.9% vs. 15.6%; odds ratio [OR], 3.35 [95% CI, 2.16 to 5.21]; P < 0.001), 9 to 24 (25.0% vs. 12.3%; OR, 2.53 [CI, 1.56 to 4.10]; P < 0.001), and 9 to 52 (20.3% vs. 10.4%; OR, 2.36 [CI, 1.40 to 3.98]; P = 0.001). There were no clinically relevant differences between groups in suicidal ideation or behavior and no overall worsening of depression or anxiety in either group. The most frequent adverse event was nausea (varenicline, 27.0%; placebo, 10.4%). Two varenicline-group participants died during the nontreatment phase.
  
  
  CONCLUSIONS
  Some data were missing, and power to detect differences between groups was low in rare events. Smokers with untreated depression, with co-occurring psychiatric conditions, or receiving mood stabilizers and antipsychotics were not included.
  
  
  CONCLUSIONS
  Varenicline increased smoking cessation in smokers with stably treated current or past depression without exacerbating depression or anxiety.
  
  
  BACKGROUND
  Pfizer.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Anthenelli
authors.forename: Chad
authors.initials: C
authors.lastname: Morris
authors.forename: Tanya S
authors.initials: TS
authors.lastname: Ramey
authors.forename: Sarah J
authors.initials: SJ
authors.lastname: Dubrava
authors.forename: Kostas
authors.initials: K
authors.lastname: Tsilkos
authors.forename: Cristina
authors.initials: C
authors.lastname: Russ
authors.forename: Carla
authors.initials: C
authors.lastname: Yunis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use; D001007:Anxiety; D001552:Benzazepines / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000150:complications* / Q000188:drug therapy / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D011810:Quinoxalines / Q000009:adverse effects / Q000627:therapeutic use*; D016540:Smoking Cessation / Q000379:methods* / Q000523:psychology*; D059020:Suicidal Ideation; D016896:Treatment Outcome; D000068580:Varenicline; D055815:Young Adult
chemical_list: D000928:Antidepressive Agents; D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline