Symptom Management Trial in Cancer Survivors
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.
William F. Pirl, MD
Massachusetts General Hospital
United States: Federal Government
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|