Status:
TERMINATED
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Depression
Eligibility:
All Genders
35-85 years
Phase:
PHASE3
Brief 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 pla...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00387348
Start Date
March 1 2006
End Date
April 1 2011
Last Update
December 3 2012
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114