Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066859
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2003-08-06
Brief Title:
Sertraline Compared With Hypericum Perforatum StJohns Wort in Treating Depression
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
A Phase III Double-Blind Randomized Trial Comparing Sertraline Zoloft And Hypericum Perforatum St Johns Wort In Cancer Patients With Mild To Moderate Depression
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Antidepressants such as sertraline and the herb hypericum perforatum St Johns wort may be effective in treating mild to moderate depression It is not yet known which treatment is more effective in improving depression in patients who have cancer
PURPOSE This randomized phase III trial is studying how well sertraline works compared to St Johns wort in treating mild to moderate depression in patients with solid tumors
PURPOSE This randomized phase III trial is studying how well sertraline works compared to St Johns wort in treating mild to moderate depression in patients with solid tumors
Detailed Description:
OBJECTIVES
Compare the change in depression severity in cancer patients with mild to moderate depression treated with sertraline vs Hypericum perforatum
Compare the severity of somnolence nausea and insomnia in patients treated with these regimens
Compare the impact of these regimens on fatigue in these patients
Correlate hyperforin concentrations with change in depression severity in patients treated with Hypericum perforatum
OUTLINE This is a randomized double-blind study Patients are stratified according to level of depression mild vs moderate concurrent radiotherapy yes vs no and TNM stage I II or III vs IV Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sertraline daily
Arm II Patients receive oral Hypericum perforatum daily In both arms treatment continues for 4 months in the absence of unacceptable toxicity
Measurements of depression somnolence nausea insomnia fatigue and hyperforin concentration are assessed at baseline and at 1 2 and 4 months
PROJECTED ACCRUAL A maximum of 250 patients will be accrued for this study
Compare the change in depression severity in cancer patients with mild to moderate depression treated with sertraline vs Hypericum perforatum
Compare the severity of somnolence nausea and insomnia in patients treated with these regimens
Compare the impact of these regimens on fatigue in these patients
Correlate hyperforin concentrations with change in depression severity in patients treated with Hypericum perforatum
OUTLINE This is a randomized double-blind study Patients are stratified according to level of depression mild vs moderate concurrent radiotherapy yes vs no and TNM stage I II or III vs IV Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral sertraline daily
Arm II Patients receive oral Hypericum perforatum daily In both arms treatment continues for 4 months in the absence of unacceptable toxicity
Measurements of depression somnolence nausea insomnia fatigue and hyperforin concentration are assessed at baseline and at 1 2 and 4 months
PROJECTED ACCRUAL A maximum of 250 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 |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |