Escitalopram in Treating Depression in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
| Status: | Archived |
|---|---|
| Conditions: | Lung Cancer, Cancer, Depression, Other Indications, Psychiatric |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
Symptom Management Trial in Cancer Survivors
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.
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.
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