Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer
Intervention: escitalopram oxalate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s): William F. Pirl, MD, Study Chair, Affiliation: Massachusetts General Hospital
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.
Clinical Details
Official title: Symptom Management Trial in Cancer Survivors
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive DisorderChange in Hamilton Depression Rating Scale (HAM-D) Scores
Secondary outcome: Side Effect Burden
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
Minimum age: 35 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: March 2006
Last updated: November 2, 2012
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