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Cola

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

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

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 oxalate 10 mg once daily for 4 weeks

escitalopram oxalate

one placebo pill identical in appearance to the escitalpram pill once daily

Placebo

William F. Pirl, MD

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.

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

Symptom Management Trial in Cancer Survivors

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.

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.

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.

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks

Placebo-Placebo

Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks

Placebo-Escitalopram

Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks

Escitalopram-Placebo

Total

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

After an interim analaysis, the DSMB decided to terminate the trial early because of the rate of adverse events (HAM-D scores increasing by at least 25%) and deaths were higher in participants receiving placebo.

William F Pirl, MD

Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks

Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks

Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks

The efficacy analysis was intent to treat and all randomized participants were analyzed

Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder

Participants who completed the 4 week assessment were analyzed

Side Effect Burden

Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks

Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks

Participants who had at least 1 follow up HAM-D assessment were included. Two participants died, one without a follow up assessment and one with a HAM-D at 2 weeks. For the participant who had the HAM-D at 2 weeks and then died, the last endpoint was carried forward.

Change in Hamilton Depression Rating Scale (HAM-D) Scores

Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.

Overall Study

Spots Global Cancer Trial Database for escitalopram oxalate