Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Condition: Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Fatigue; Depression; Depressive Disorder
Intervention: escitalopram oxalate; Placebo
Intervention description: escitalopram oxalate 10 mg once daily for 4 weeks; one placebo pill identical in appearance to the escitalpram pill once daily
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: fatigue; psychosocial effects of cancer and its treatment; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; extensive stage small cell lung cancer; advanced adult primary liver cancer; depression; stage III pancreatic cancer; stage IV pancreatic cancer; stage IV esophageal cancer; stage IV gastric cancer; stage IVA colon cancer; stage IVB colon cancer; stage IVA rectal cancer; stage IVB rectal cancer; unresectable gallbladder cancer; unresectable extrahepatic bile duct 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.
    

Eligibility criteria:

        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