Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339066
Status:
COMPLETED
Last Update Posted:
2013-08-09
First Post:
2006-06-16
Brief Title:
Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Treatment Outcomes of Vascular Depression
Status:
COMPLETED
Status Verified Date:
2008-02
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:
This study will determine the relationship between brain lesion severity treatment response and frontal lobe brain function in people with late-life depression LLD
Detailed Description:
Depression in older adults is a major public health problem and it often goes underdiagnosed and undertreated A significant number of people with LLD especially those with cerebrovascular risk factors have subcortical grey matter and frontal deep white matter brain lesions Some studies suggest that these lesions or hyperintensities may be associated with poor acute and long-term depression treatment response Similarly studies have shown that people with LLD frequently have functional deficits in the frontal lobe portion of their brains This dysfunction has been shown to be associated with poor acute treatment response with a tricyclic antidepressant drug as well as with a greater risk for depression relapse The applicability of these findings to other classes of antidepressant medications such as selective serotonin reuptake inhibitors SSRIs however remains unknown Additionally more information is needed about the interaction between frontal brain lesions and executive function deficits in LLD This study will determine the relationship between brain lesion severity treatment response and frontal lobe function in people with late-life depression who are being treated with the SSRI sertraline
Participants in this open label study will first undergo neuropsychological testing to determine eligibility All eligible participants will be treated with sertraline for 12 weeks Dosages will begin at 25 mg per day and will be increased to 50 mg per day after 4 days Any other dosage modifications will depend on the participants individual response to the medication All participants will have an MRI scan at some point during the study Assessments of symptoms and treatment response will occur at the study site biweekly until Week 8 and then again at Week 12
Participants in this open label study will first undergo neuropsychological testing to determine eligibility All eligible participants will be treated with sertraline for 12 weeks Dosages will begin at 25 mg per day and will be increased to 50 mg per day after 4 days Any other dosage modifications will depend on the participants individual response to the medication All participants will have an MRI scan at some point during the study Assessments of symptoms and treatment response will occur at the study site biweekly until Week 8 and then again at Week 12
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 |
|---|---|---|---|
| R01MH062158 | NIH | None | None |
| DATR A4-GPX | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH062158 |