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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Symptom Management Trial in Cancer Survivors

Conditions
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Fatigue, Colorectal Cancer, Depression, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Liver Cancer, Lung Cancer, Pancreatic Cancer

Intervention / Treatment
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* Drug: escitalopram oxalate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo-Placebo<br>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<br>* one placebo pill identical in appearance to the escitalpram pill once daily<br>|
| Other: Placebo-Escitalopram<br>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<br>* escitalopram oxalate 10 mg once daily for 4 weeks<br>Drug: Placebo<br>* one placebo pill identical in appearance to the escitalpram pill once daily<br>|
| Other: Escitalopram-Placebo<br>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<br>* escitalopram oxalate 10 mg once daily for 4 weeks<br>Drug: Placebo<br>* one placebo pill identical in appearance to the escitalpram pill once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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