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

Phase 3TerminatedNCT00387348

Massachusetts General Hospital24 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 4 weeks

Secondary Outcomes

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.

Time frame: 4 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes