Escitalopram in Treating Depression in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Condition(s) targeted: Cancer-Related Problem/Condition; Fatigue; Lung Cancer

Intervention: escitalopram oxalate (Drug); fatigue assessment and management (Procedure); management of therapy complications (Procedure); quality-of-life assessment (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Massachusetts General Hospital

Official(s) and/or principal investigator(s):
William F. Pirl, MD, Study Chair, Affiliation: Massachusetts General Hospital

RATIONALE: Escitalopram may help improve depression and quality of life in patients with non-small cell lung cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with non-small cell lung 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 stage IIIB or stage IV non-small cell lung cancer.

Official title: Symptom Management Trial in Cancer Survivors

Study design: Supportive Care, Randomized, Double-Blind, Placebo Control

Primary outcome:

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

Secondary outcome:

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])

Detailed description: OBJECTIVES:

- 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.

- 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 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.

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

Minimum age: 35 Years. Maximum age: 85 Years. Gender(s): Both.

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

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

PRIOR CONCURRENT THERAPY:

- No other concurrent antidepressant medications or psychostimulants

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Clinical Trials Office - Massachusetts General Hospital, Phone: 877-726-5130

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: March 2006
Last updated: October 18, 2008