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

Depression Clinical Trial

Official title:

Symptom Management Trial in Cancer Survivors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00387348
• Other study ID #: CDR0000505774
• Secondary ID: MGH-2006-P-00029
• Status: Terminated
• Phase: Phase 3
• First received: October 12, 2006
• Last updated: November 2, 2012
• Start date: March 2006
• Est. completion date: April 2011

Study information

• Verified date: November 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cholangiocarcinoma
• Colorectal Cancer
• Depression
• Depressive Disorder
• Esophageal Cancer
• Esophageal Neoplasms
• Extrahepatic Bile Duct Cancer
• Fatigue
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
• Placebo
one placebo pill identical in appearance to the escitalpram pill once daily

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder	Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.	4 weeks	No
Primary	Change in Hamilton Depression Rating Scale (HAM-D) Scores	The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range.	4 weeks	No
Secondary	Side Effect Burden	Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144.	4 weeks	Yes