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

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: Citalopram; Dexetimide

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