Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626152
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression a Pilot Feasibility Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression a Pilot Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LLDOPA
Brief Summary:
Background
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression LLD a condition that usually decreases a persons quality of life and is associated with other risks like physical frailty and dementia A common feature of more severe LLD is psychomotor slowing where a persons ability to think and move are impaired For example they might not be able to walk or process information as quickly and they might have problems with their working memory
Psychomotor slowing in LLD might be the result of a problem with the way a persons body produces or responds to the neurotransmitter dopamine The drug Levodopa L-DOPA which can replace missing dopamine in the brain has been used to treat to treat Parkinsons disease for many decades and it might also affect psychomotor slowing in LLD
Methods
In this study participants are adults aged 60 years or older with moderate to severe major depression Participants undergo the L-DOPA challenge-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week Before and after a participant completes the L-DOPA challenge the study team assesses their depressive symptoms and psychomotor function After the L-DOPA challenge if a participant still shows signs of moderate or severe depression they receive an antidepressant for 12 weeks
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is whether most of the 50 participants recruited for this study will complete the L-DOPA challenge For example participants might have to withdraw if they cant make the daily visits to the research site to receive their L-DOPA medication if they cant tolerate the medications side effects or if their depressive symptoms get significantly worse Our hypothesis is that 80 of the participants will complete the L-DOPA challenge
The second aim of the study is to see if L-DOPA affects participants depressive symptoms processing speed and working memory Our hypothesis is that L-DOPA response measured as an improvement in gait speed is associated with a decrease in depressive symptoms and an increase in processing speed and working memory
Adults over the age of 60 with symptoms of major depressive disorder are said to have late-life depression LLD a condition that usually decreases a persons quality of life and is associated with other risks like physical frailty and dementia A common feature of more severe LLD is psychomotor slowing where a persons ability to think and move are impaired For example they might not be able to walk or process information as quickly and they might have problems with their working memory
Psychomotor slowing in LLD might be the result of a problem with the way a persons body produces or responds to the neurotransmitter dopamine The drug Levodopa L-DOPA which can replace missing dopamine in the brain has been used to treat to treat Parkinsons disease for many decades and it might also affect psychomotor slowing in LLD
Methods
In this study participants are adults aged 60 years or older with moderate to severe major depression Participants undergo the L-DOPA challenge-a 2-week period where they receive a dose of L-DOPA once a day for the first week and a dose of L-DOPA twice a day for the second week Before and after a participant completes the L-DOPA challenge the study team assesses their depressive symptoms and psychomotor function After the L-DOPA challenge if a participant still shows signs of moderate or severe depression they receive an antidepressant for 12 weeks
Aims
The first aim of this study is to test the feasibility of the L-DOPA challenge-that is whether most of the 50 participants recruited for this study will complete the L-DOPA challenge For example participants might have to withdraw if they cant make the daily visits to the research site to receive their L-DOPA medication if they cant tolerate the medications side effects or if their depressive symptoms get significantly worse Our hypothesis is that 80 of the participants will complete the L-DOPA challenge
The second aim of the study is to see if L-DOPA affects participants depressive symptoms processing speed and working memory Our hypothesis is that L-DOPA response measured as an improvement in gait speed is associated with a decrease in depressive symptoms and an increase in processing speed and working memory
Detailed Description:
None
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