Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387348
Status:
TERMINATED
Last Update Posted:
2012-12-03
First Post:
2006-10-12
Brief Title:
Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Symptom Management Trial in Cancer Survivors
Status:
TERMINATED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB stopped study because placebo arm had more adverse events
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23CA115908 | NIH | None | httpsreporternihgovquickSearchK23CA115908 |
| MGH-2006-P-000299 | None | None | None |