• 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])

RATIONALE: Escitalopram may help improve depression and quality of life in patients with non-small cell lung cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with non-small cell lung cancer.

PURPOSE: This randomized clinical trial is studying the side effects of escitalopram and to see how well it works compared to a placebo in treating depression in patients with stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES:

• Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with stage IIIB or IV non-small cell lung 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.

• Depression
• Fatigue
• Lung Cancer
• Psychosocial Effects of Cancer and Its Treatment

• Drug: escitalopram oxalate
• Procedure: fatigue assessment and management
• Procedure: management of therapy complications
• Procedure: quality-of-life assessment

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer

  • Stage IIIB (with effusions) or stage IV disease diagnosed ≥ 8 weeks ago
• Meets diagnostic and Statistical Manual of Mental Disorders-4th Edition and Endicott criteria for major depressive disorder
• Duration of depressive symptoms ≥ 4 weeks
• Hamilton Depression Scale ≥ 14
• No active suicidality requiring immediate care or psychiatric hospitalization

PATIENT CHARACTERISTICS:

• No active substance abuse disorder (including alcohol abuse within the past 6 months), psychotic disorder or active psychotic symptoms, organic mental disorders, or bipolar disorder
• No clinical or laboratory evidence of hypothyroidism
• No hypercalcemia
• No severe anemia, defined as hemoglobin < 10 g/dL
• No history of multiple adverse drug reactions or allergy to study drugs

PRIOR CONCURRENT THERAPY:

• No other concurrent antidepressant medications or psychostimulants