• Efficacy of escitalopram oxalate or placebo in treating a major depressive disorder as measured by Hamilton Depression scores at baseline, 4 weeks, and 8 weeks
  
• Side effect burden of treatment as measured by the sum of the symptom severity scores on the UKU Side Effects Rating Scale at 4 and 8 weeks
  

• Moderators of efficacy as measured by medical variables (pain assessed by FACT-L, narcotic use, specific type of cancer treatment, cancer-related fatigue assessed by the FACIT-F, and adherence to study medications)
  
• Psychological variables other than depression (anxiety and somatization as assessed by the Brief Symptom Inventory 18 and treatment expectancy)
  
• Social variables (perceived social support assessed by the Social Support Questionnaire, stress and negative life events assessed by the Life Expectancy Survey, and sociodemographic variables [e.g., age and gender])
  

OBJECTIVES:

• Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with advanced lung or gastrointestinal cancer.
• Compare the side effect burden of escitalopram oxalate vs placebo in these patients.
• Determine potential moderators of the efficacy of escitalopram oxalate in these patients, including medical, psychological, and social variables.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to stage of disease (stage IIIB with effusions vs stage IV) and current treatment (radiation vs chemotherapy vs novel agent). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral escitalopram oxalate once daily for up to 8 weeks.
• Arm II: Patients receive oral placebo once daily for up to 8 weeks. After 8 weeks, all non-responders are offered open treatment with an antidepressant.

Depression, fatigue, quality of life, anxiety, and somatization are assessed at baseline and then at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.