Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177671
Status:
COMPLETED
Last Update Posted:
2013-02-06
First Post:
2005-09-13
Brief Title:
Antidepressant Medication Plus Donepezil for Treating Late-life Depression
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Maintenance Therapies in Late-Life Depression MTLD III
Status:
COMPLETED
Status Verified Date:
2013-01
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 effectiveness of combining escitalopram venlafaxine or duloxetine with donepezil a medication used in Alzheimers disease in improving memory concentration attention and problem solving abilities and reducing the risk of depressive relapse in older individuals with depression
Detailed Description:
The purpose of this research study is to learn if combining an antidepressant medication escitalopram venlafaxine or duloxetine with a medication used in Alzheimers Disease donepezil in elderly patients age 65 and older with major depression will help to 1 improve andor maintain memory concentration attention and problem solving abilities such as ability to balance a checkbook pay bills use the telephone and 2 reduce the risk of depressive symptoms from returning Study participation will last up to two years
We aim to investigate pharmacologic strategies for improving and stabilizing cognitive functioning in late-life depression and minimizing progression of cognitive and associated functional impairment Cognitive impairment in late-life depression has not been adequately addressed in previous intervention research is a core feature of the illness contributes markedly to disability and impaired quality of life and is an overlooked but potentially critical target of intervention Data from the MTLD II study suggest that treating depression does not normalize cognitive functions and may not prevent their progression We will test a pharmacologic strategy involving the cholinesterase inhibitor donepezil in combination with maintenance antidepressant pharmacotherapy escitalopram venlafaxine or duloxetine to improve and to maintain cognitive functioning and functional competence in elderly patients with major depression
We hypothesize that maintenance antidepressant pharmacotherapy combined with donepezil will be superior to maintenance antidepressant pharmacotherapy combined with placeboclinical management in 1 improving cognitive performance and 2 slowing progression of cognitive impairment and decline in functional competence We plan to recruit 200 patients aged 65 and above in current episodes of major depression Those who respond to antidepressant pharmacotherapy with citalopram venlafaxine or duloxetine will then be randomly assigned on a double-blind basis to one of two 24-month treatments 1antidepressant pharmacotherapy plus donepezilclinical management or 2antidepressant pharmacotherapy plus placeboclinical management
For information on related studies please follow these links
httpclinicaltrialsgovshowNCT00000377
httpclinicaltrialsgovshowNCT00178100
We aim to investigate pharmacologic strategies for improving and stabilizing cognitive functioning in late-life depression and minimizing progression of cognitive and associated functional impairment Cognitive impairment in late-life depression has not been adequately addressed in previous intervention research is a core feature of the illness contributes markedly to disability and impaired quality of life and is an overlooked but potentially critical target of intervention Data from the MTLD II study suggest that treating depression does not normalize cognitive functions and may not prevent their progression We will test a pharmacologic strategy involving the cholinesterase inhibitor donepezil in combination with maintenance antidepressant pharmacotherapy escitalopram venlafaxine or duloxetine to improve and to maintain cognitive functioning and functional competence in elderly patients with major depression
We hypothesize that maintenance antidepressant pharmacotherapy combined with donepezil will be superior to maintenance antidepressant pharmacotherapy combined with placeboclinical management in 1 improving cognitive performance and 2 slowing progression of cognitive impairment and decline in functional competence We plan to recruit 200 patients aged 65 and above in current episodes of major depression Those who respond to antidepressant pharmacotherapy with citalopram venlafaxine or duloxetine will then be randomly assigned on a double-blind basis to one of two 24-month treatments 1antidepressant pharmacotherapy plus donepezilclinical management or 2antidepressant pharmacotherapy plus placeboclinical management
For information on related studies please follow these links
httpclinicaltrialsgovshowNCT00000377
httpclinicaltrialsgovshowNCT00178100
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 |
|---|---|---|---|
| R01MH043832 | NIH | None | None |
| 0312018 | None | None | None |
| DATR A4-GPS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH043832 |