Patient case: 54-year-old male with Gastric cancer. Genetic variant: PIK3CA (E545K). Other conditions: Depression.

Clinical trial: Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer

Summary: 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.

Detailed description: 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.

Eligibility: 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

Relevance to patient case: not relevant