Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
NCT ID: NCT00387348
Last Updated: 2012-12-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
PHASE3
24 participants
INTERVENTIONAL
2006-03-31
2011-04-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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
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
escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
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
escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
Interventions
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escitalopram oxalate
escitalopram oxalate 10 mg once daily for 4 weeks
Placebo
one placebo pill identical in appearance to the escitalpram pill once daily
Eligibility Criteria
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Inclusion Criteria
* 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
35 Years
85 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Massachusetts General Hospital
OTHER
Responsible Party
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William Pirl
Principal Investigator
Principal Investigators
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William F. Pirl, MD
Role: STUDY_CHAIR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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MGH-2006-P-000299
Identifier Type: -
Identifier Source: secondary_id
CDR0000505774
Identifier Type: -
Identifier Source: org_study_id