search
Back to results

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

Primary Purpose

Colorectal Cancer, Depression, Esophageal Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
escitalopram oxalate
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring fatigue, psychosocial effects of cancer and its treatment, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, advanced adult primary liver cancer, depression, stage III pancreatic cancer, stage IV pancreatic cancer, stage IV esophageal cancer, stage IV gastric cancer, stage IVA colon cancer, stage IVB colon cancer, stage IVA rectal cancer, stage IVB rectal cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Other

Other

Arm Label

Placebo-Placebo

Placebo-Escitalopram

Escitalopram-Placebo

Arm Description

Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks

Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks

Participants in this arm were randomzied to receive escitalopram 10 mg once daily for the first 4 weeks and placebo once daily for the second 4 weeks

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 12, 2006
Last Updated
November 2, 2012
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00387348
Brief Title
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Official Title
Symptom Management Trial in Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Why Stopped
DSMB stopped study because placebo arm had more adverse events
Study Start Date
March 2006 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Fatigue, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer
Keywords
fatigue, psychosocial effects of cancer and its treatment, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, extensive stage small cell lung cancer, advanced adult primary liver cancer, depression, stage III pancreatic cancer, stage IV pancreatic cancer, stage IV esophageal cancer, stage IV gastric cancer, stage IVA colon cancer, stage IVB colon cancer, stage IVA rectal cancer, stage IVB rectal cancer, unresectable gallbladder cancer, unresectable extrahepatic bile duct cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo-Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and placebo once daily for the second 4 weeks
Arm Title
Placebo-Escitalopram
Arm Type
Other
Arm Description
Participants in this arm were randomized to receive placebo once daily for the first 4 weeks and escitalopram oxalate 10 mg once daily for the second 4 weeks
Arm Title
Escitalopram-Placebo
Arm Type
Other
Arm Description
Participants in this arm were randomzied to receive escitalopram 10 mg once daily for the first 4 weeks and placebo once daily for the second 4 weeks
Intervention Type
Drug
Intervention Name(s)
escitalopram oxalate
Intervention Description
escitalopram oxalate 10 mg once daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
one placebo pill identical in appearance to the escitalpram pill once daily
Primary Outcome Measure Information:
Title
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
Description
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.
Time Frame
4 weeks
Title
Change in Hamilton Depression Rating Scale (HAM-D) Scores
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Side Effect Burden
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William F. Pirl, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs