Clinical trial NCT00387348
Conditions: Colorectal Cancer Depression Esophageal Cancer Extrahepatic Bile Duct Cancer Fatigue Gallbladder Cancer Gastric Cancer Liver Cancer Lung Cancer Pancreatic Cancer
Keywords: 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
Sponsor: Massachusetts General Hospital
Start date: 2006-03-01; Completion date: 2011-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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 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.

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.

Arms: arm 1: 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 arm 2: 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 arm 3: 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
Interventions: intervention 1: escitalopram oxalate intervention 2: Placebo
Intervention descriptions: intervention 1: escitalopram oxalate 10 mg once daily for 4 weeks intervention 2: one placebo pill identical in appearance to the escitalpram pill once daily

Protocol documents: