DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer

Intervention: escitalopram oxalate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Massachusetts General Hospital

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

Summary

RATIONALE: Escitalopram may help improve depression and quality of life in patients with advanced lung or gastrointestinal cancer. It is not yet known whether escitalopram is more effective than a placebo in treating depression in patients with advanced lung or gastrointestinal 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 advanced lung or gastrointestinal cancer.

Clinical Details

Official title: Symptom Management Trial in Cancer Survivors

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome:

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder

Change in Hamilton Depression Rating Scale (HAM-D) Scores

Secondary outcome: Side Effect Burden

Detailed description: OBJECTIVES:

- Compare the efficacy of escitalopram oxalate vs placebo in treating major depressive

disorder in patients with advanced lung or gastrointestinal 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 placebo once daily for 4 weeks followed by oral placebo

once daily for another 4 weeks

- Arm II: Patients receive oral placebo once daily for 4 weeks followed by escitalopram

oxalate 10 mg once daily for 4 weeks.

- Arm III: Patients receive oral escitalopram oxalate 10 mg once daily for 4 weeks

followed by oral placebo once daily for 4 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

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

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

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

PRIOR CONCURRENT THERAPY:

- No other concurrent antidepressant medications or psychostimulants

Locations and Contacts

Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information

Starting date: March 2006
Last updated: November 2, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017