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

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ClinicalTrials.gov Identifier: NCT00387348
Recruitment Status : Terminated (DSMB stopped study because placebo arm had more adverse events)
First Posted : October 13, 2006
Results First Posted : December 3, 2012
Last Update Posted : December 3, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Pirl, Massachusetts General Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Depression Esophageal Cancer Extrahepatic Bile Duct Cancer Fatigue Gallbladder Cancer Gastric Cancer Liver Cancer Lung Cancer Pancreatic Cancer Drug: escitalopram oxalate Drug: Placebo Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Symptom Management Trial in Cancer Survivors
Study Start Date : March 2006
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo-Placebo
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
 Drug: Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
Placebo-Escitalopram
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
 Drug: escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks

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

Drug: Placebo
one placebo pill identical in appearance to the escitalpram pill once daily


Outcome Measures
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Primary Outcome Measures :
  1. Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder [ Time Frame: 4 weeks ]
    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.

  2. Change in Hamilton Depression Rating Scale (HAM-D) Scores [ Time Frame: 4 weeks ]
    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 :
  1. Side Effect Burden [ Time Frame: 4 weeks ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00387348


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Study Chair: William F. Pirl, MD Massachusetts General Hospital
More Information
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Responsible Party: William Pirl, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00387348    
Other Study ID Numbers: CDR0000505774
MGH-2006-P-000299
K23CA115908 ( U.S. NIH Grant/Contract )
First Posted: October 13, 2006    Key Record Dates
Results First Posted: December 3, 2012
Last Update Posted: December 3, 2012
Last Verified: November 2012
Keywords provided by William Pirl, Massachusetts General Hospital:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Cholangiocarcinoma
Fatigue
Depression
Depressive Disorder
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Head and Neck Neoplasms
Esophageal Diseases