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

Phase 3

Terminated

• Conditions: Colorectal Cancer; Depression; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Fatigue; Gallbladder Cancer; Gastric Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer
• Interventions: Drug: Placebo; Drug: escitalopram oxalate

• Registration Number: NCT00387348
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-10-12
• Study First Submitted QC: 2006-10-12
• Study First Posted: 2006-10-13
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-07-12
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-02
• Last Update Submitted: 2012-11-02
• Results First Posted: 2012-12-03
• Last Update Posted: 2012-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo-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-Escitalopram	escitalopram oxalate	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
Placebo-Escitalopram	Placebo	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-Placebo	escitalopram oxalate	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-Placebo	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

Primary Outcome Measures

Name	Time	Method
Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder	4 weeks	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.
Change in Hamilton Depression Rating Scale (HAM-D) Scores	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Side Effect Burden	4 weeks	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States