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 Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Active 35 to 85 NCI MGH-2006-P-000299 NCT00387348

Objectives

1. Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive disorder in patients with stage IIIB or IV non-small cell lung 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 non-small cell lung cancer
  • Stage IIIB (with effusions) or stage IV disease diagnosed ≥ 8 weeks ago



• 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 Scale ≥ 14



• No active suicidality requiring immediate care or psychiatric hospitalization

Prior/Concurrent Therapy:

• No other concurrent antidepressant medications or psychostimulants

Patient Characteristics:

• 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

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

U.S.A.
Massachusetts
	Boston
	Massachusetts General Hospital
		Clinical Trials Office - Massachusetts General Hospital	Ph:  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		2008-12-28
NCI Grant/Contract Number		CA1154908

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