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| ID | Type | Description | Link |
|---|---|---|---|
| MGH-2006-P-000299 | |||
| K23CA115908 | U.S. NIH Grant/Contract | View source |
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DSMB stopped study because placebo arm had more adverse events
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo-Placebo | Placebo Comparator | 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 |
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| Placebo-Escitalopram | Other | 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 |
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| Escitalopram-Placebo | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram oxalate | Drug | escitalopram oxalate 10 mg once daily for 4 weeks |
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| 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 |
| 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 |
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DISEASE CHARACTERISTICS:
Diagnosis of any of the following for at least 4 weeks:
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William F. Pirl, MD | Massachusetts General Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
After enrollment, participants completed an assessment for major depressive disorder. 90 participants consented for study evaluation. In order to be randomized to a group, participants had to meet criteria for major depressive disorder. Of the 90 evaluated on study, only 24 were randomized.
Participants were recruited from the ambulatory thoracic and GI cancer clinics at MGH. Recruitment was open from 11/1/06 until 4/1/11.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-Placebo | 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. |
| FG001 | Placebo-Escitalopram |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | one placebo pill identical in appearance to the escitalpram pill once daily |
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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
| FG002 | Escitalopram-Placebo | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-Placebo | Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks |
| BG001 | Placebo-Escitalopram | Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks |
| BG002 | Escitalopram-Placebo | Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The efficacy analysis was intent to treat and all randomized participants were analyzed | Posted | Number | number of participants with response | 4 weeks |
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| Secondary | 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. | Participants who completed the 4 week assessment were analyzed | Posted | Mean | Standard Deviation | units on a scale | 4 weeks |
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| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Change in HAM-D scores | 4 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo-Placebo | Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks | 1 | 8 | 1 | 8 | ||
| EG001 | Placebo-Escitalopram | Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks | 1 | 5 | 0 | 5 | ||
| EG002 | Escitalopram-Placebo | Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks | 0 | 11 | 1 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAM-D score increased by at least 25% | Psychiatric disorders | Systematic Assessment |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William F Pirl, MD | Massachusetts General Hospital | 617-724-9151 | wpirl@partners.org |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003863 | Depression |
| D004938 | Esophageal Neoplasms |
| D001650 | Bile Duct Neoplasms |
| D005221 | Fatigue |
| D005706 | Gallbladder Neoplasms |
| D013274 | Stomach Neoplasms |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D001661 | Biliary Tract Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005705 | Gallbladder Diseases |
| D013272 | Stomach Diseases |
| D008107 | Liver Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Counts |
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| Participants |
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