Clinical trial NCT00387348: Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Official title: Symptom Management Trial in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
timeFrame: 4 weeks
measure: Change in Hamilton Depression Rating Scale (HAM-D) Scores
timeFrame: 4 weeks
Secondary outcomes:
measure: Side Effect Burden
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: William F. Pirl, MD
role: STUDY_CHAIR
References: