Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer

Basic Trial Information

Objectives

1. Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with advanced lung or gastrointestinal cancer.
2. Compare the side effect burden of escitalopram oxalate vs placebo in these patients.
3. Determine potential moderators of the efficacy of escitalopram oxalate in these patients, including medical, psychological, and social variables.

Entry 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

Prior/Concurrent Therapy:

• No other concurrent antidepressant medications or psychostimulants

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

Expected Enrollment

A total of 220 patients will be accrued for this study.

Outcomes

Efficacy of escitalopram oxalate or placebo in treating a major depressive disorder as measured by Hamilton Depression scores at baseline, 4 weeks, and 8 weeks
Side effect burden of treatment as measured by the sum of the symptom severity scores on the UKU Side Effects Rating Scale at 4 and 8 weeks

Moderators of efficacy as measured by medical variables (pain assessed by FACT-L, narcotic use, specific type of cancer treatment, cancer-related fatigue assessed by the FACIT-F, and adherence to study medications)
Psychological variables other than depression (anxiety and somatization as assessed by the Brief Symptom Inventory 18 and treatment expectancy)
Social variables (perceived social support assessed by the Social Support Questionnaire, stress and negative life events assessed by the Life Expectancy Survey, and sociodemographic variables [e.g., age and gender])

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 escitalopram oxalate once daily for up to 8 weeks.

• Arm II: Patients receive oral placebo once daily for up to 8 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.

Trial Contact Information

Trial Lead Organizations

Massachusetts General Hospital

William Pirl, MD, Protocol chair		Ph: 617-724-9151; 877-726-5130

Registry Information
Official Title		Symptom Management Trial in Cancer Survivors
Trial Start Date		2006-03-07
Trial Completion Date		2011-04-30 (estimated)
Registered in ClinicalTrials.gov		NCT00387348
Date Submitted to PDQ		2006-08-21
Information Last Verified		2009-06-28
NCI Grant/Contract Number		CA1154908

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