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

Mass General Brigham

Status and phase: Terminated; Phase 3

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

Treatments: Drug: escitalopram oxalate; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00387348

K23CA115908 (U.S. NIH Grant/Contract)

CDR0000505774

MGH-2006-P-000299

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Placebo-Placebo

Placebo Comparator group

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

Treatment:

Drug: Placebo

Placebo-Escitalopram

Other group

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

Treatment:

Drug: escitalopram oxalate

Drug: Placebo

Escitalopram-Placebo

Other group

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

Treatment:

Drug: escitalopram oxalate

Drug: Placebo