Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Colorectal Cancer, Depression, Esophageal Cancer
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring 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
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Other
Other
Placebo-Placebo
Placebo-Escitalopram
Escitalopram-Placebo
Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks
Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks
Participants in this arm were randomzied to receive escitalopram 10 mg once daily for the first 4 weeks and placebo once daily for the second 4 weeks