St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Location status: Recruiting
NCT Number: NCT06626152
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 person's 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 person's 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 person's 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 Parkinson's 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 can't make the daily visits to the research site to receive their L-DOPA medication, if they can't tolerate the medication's 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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Phase 2
Vancouver, British Columbia, V6Z 1Y6, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
As above.
Time frame: 6 months
Number of participants who complete the 2-week challenge of receiving L-DOPA and post-challenge assessments
Time frame: At 2, 3, 7, and 15 weeks from baseline
Change in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale, after the L-DOPA challenge and after treatment for depression
Time frame: At baseline and 2 weeks from baseline
Change in gait speed in response to L-DOPA, as measured by time to complete the 4-metre walk test.
Time frame: At baseline and 2 weeks from baseline
Changes in psychomotor speed in response to L-DOPA, as measured by the clinician-rated CORE instrument
Time frame: At 2 and 15 weeks from baseline
Change in processing speed, as measured by the NIH Toolbox Cognitive Battery: Pattern Comparison tool, after the L-DOPA challenge and after treatment for depression
Time frame: At 2 and 15 weeks from baseline
Change in working memory, as measured by the NIH Toolbox Cognitive Battery: List Sorting tool, after the L-DOPA challenge and after treatment for depression
Time frame: At 2 weeks from baseline
Incidence, frequency, and severity of side effects following L-DOPA administration, related to the cardiovascular, respiratory, musculoskeletal, genitourinary, skin, and central nervous systems, as recorded on an Adverse Effects Monitoring Form
Contact information is provided by the study sponsor or research team.
University of British Columbia
Other
Acronym: LLDOPA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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