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

Sponsor:	Massachusetts General Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00387348

Purpose

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.

Condition	Intervention
Depression Fatigue Lung Cancer Psychosocial Effects of Cancer and Its Treatment	Drug: escitalopram oxalate Procedure: fatigue assessment and management Procedure: management of therapy complications Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	Symptom Management Trial in Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer Depression Lung Cancer

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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 Measures:

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])

Estimated Enrollment:	220
Study Start Date:	March 2006
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	35 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00387348

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Study Chair:

William F. Pirl, MD

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000505774, MGH-2006-P-000299
Study First Received:	October 12, 2006
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00387348 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

fatigue
psychosocial effects of cancer and its treatment
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
depression

Additional relevant MeSH terms:

Thoracic Neoplasms
Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Signs and Symptoms
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms

Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Dexetimide
Antidepressive Agents
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Fatigue
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Citalopram
Pharmacologic Actions
Carcinoma
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 09, 2009