title: Prevention of depression with escitalopram in patients undergoing treatment for head and neck cancer: randomized, double-blind, placebo-controlled clinical trial.
abstract: OBJECTIVE
  Major depressive disorder develops in up to half the patients undergoing treatment for head and neck cancer, resulting in significant morbidity; therefore, preventing depression during cancer treatment may be of great benefit.
  
  
  OBJECTIVE
  To determine whether prophylactic use of the antidepressant escitalopram oxalate would decrease the incidence of depression in patients receiving primary therapy for head and neck cancer.
  
  
  METHODS
  A randomized, double-blind, placebo-controlled trial of escitalopram vs placebo was conducted in a group of nondepressed patients diagnosed as having head and neck cancer who were about to enter cancer treatment. Patients were stratified by sex, site, stage (early vs advanced), and primary modality of treatment (radiation vs surgery).
  
  
  METHODS
  The primary outcome measure was the number of participants who developed moderate or greater depression (scores on the Quick Inventory of Depressive Symptomology-Self Rated of ≥11).
  
  
  RESULTS
  From January 6, 2008, to December 28, 2011, 148 patients were randomized. Significantly fewer patients receiving escitalopram developed depression (24.6% in the placebo group vs 10.0% in the escitalopram group; stratified log-rank test, P = .04). A Cox proportional hazards regression model compared the 2 treatment groups after controlling for age, baseline smoking status, and stratification variables. The hazard ratio of 0.37 (95% CI, 0.14-0.96) demonstrated an advantage of escitalopram (P = .04). Patients undergoing radiotherapy as the initial modality were significantly more likely to develop depression than those undergoing surgery (radiotherapy compared with surgery group; hazard ratio, 3.6; 95% CI, 1.38-9.40; P = .009). Patients in the escitalopram group who completed the study and were not depressed rated their overall quality of life as significantly better for 3 consecutive months after cessation of drug use.
  
  
  CONCLUSIONS
  In nondepressed patients undergoing treatment for head and neck cancer, prophylactic escitalopram reduced the risk of developing depression by more than 50%. In nondepressed patients who completed the trial, quality of life was also significantly better for 3 consecutive months after cessation of drug use in the escitalopram group. These findings have important implications for the treatment of patients with head and neck cancer.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00536172.
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Nebraska, USA. wmlydiat@unmc.edu
authors.forename: William M
authors.initials: WM
authors.lastname: Lydiatt
authors.forename: Diane
authors.initials: D
authors.lastname: Bessette
authors.forename: Kendra K
authors.initials: KK
authors.lastname: Schmid
authors.forename: Harlan
authors.initials: H
authors.lastname: Sayles
authors.forename: William J
authors.initials: WJ
authors.lastname: Burke
mesh_terms: D016009:Chi-Square Distribution; D015283:Citalopram / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D005260:Female; D006258:Head and Neck Neoplasms / Q000473:pathology / Q000523:psychology* / Q000628:therapy*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009329:Nebraska / Q000453:epidemiology; D009367:Neoplasm Staging; D010919:Placebos; D016016:Proportional Hazards Models; D011788:Quality of Life; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D015283:Citalopram; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors