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Symptom Management Trial in Cancer Survivors

Phase 3
35 Years
85 Years
Not Enrolling
Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Fatigue, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer

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Trial Information

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
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.

Inclusion Criteria


- 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


- 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


- No other concurrent antidepressant medications or psychostimulants

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder

Outcome Description:

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.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

William F. Pirl, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

March 2006

Completion Date:

April 2011

Related Keywords:

  • Colorectal Cancer
  • Depression
  • Esophageal Cancer
  • Extrahepatic Bile Duct Cancer
  • Fatigue
  • Gallbladder Cancer
  • Gastric Cancer
  • Liver Cancer
  • Lung Cancer
  • Pancreatic Cancer
  • 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
  • Colorectal Neoplasms
  • Depression
  • Depressive Disorder
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Fatigue
  • Liver Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Pancreatic Neoplasms
  • Gallbladder Neoplasms
  • Bile Duct Neoplasms
  • Gastrointestinal Neoplasms



Massachusetts General HospitalBoston, Massachusetts  02114-2617