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

Last updated: November 2, 2012
Sponsor: Massachusetts General Hospital
Overall Status: Terminated

Phase

3

Condition

Pancreatic Cancer

Gastric Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00387348
CDR0000505774
MGH-2006-P-000299
K23CA115908
  • Ages 35-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 24
Study Start date:
March 01, 2006
Estimated Completion Date:
April 30, 2011

Study 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.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.