Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer

Symptom Management Trial in Cancer Survivors

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

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 placebo once daily for 4 weeks followed by oral placebo once daily for another 4 weeks
• Arm II: Patients receive oral placebo once daily for 4 weeks followed by escitalopram oxalate 10 mg once daily for 4 weeks.
• Arm III: Patients receive oral escitalopram oxalate 10 mg once daily for 4 weeks followed by oral placebo once daily for 4 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.

DISEASE CHARACTERISTICS:

• Diagnosis of any of the following for at least 4 weeks:

  • Stage IIIB (with effusions) or stage IV non-small cell lung cancer
  • Extensive stage small cell lung cancer
  • Stage III or IV pancreatic cancer
  • Stage IV liver cancer
  • Stage III or IV gallbladder cancer
  • Stage III or IV bile duct cancer
  • Stage IV esophageal cancer
  • Stage IV gastric cancer
  • Second line stage IV colorectal cancer

• 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 D 17 (HAM-D 17) Scale ≥ 14

• No active suicidality requiring immediate care or psychiatric hospitalization

PATIENT CHARACTERISTICS:

• Able to swallow pills
• 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
• Not pregnant
• No history of head trauma
• No history of epilepsy

PRIOR CONCURRENT THERAPY:

• No other concurrent antidepressant medications or psychostimulants