NCT03761030

L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults

Targeting Dopaminergic Mechanisms of Slowing to Improve Late Life Depression

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.

Detailed description

Enrolled participants were aged 60 and older with (1) a DSM 5 depressive disorder, (2) significant depressive symptoms, and (3) decreased thinking or walking speed will receive 8 weeks of treatment with L-DOPA up to 450mg. We will test whether L-DOPA increases brain dopamine release using neuroimaging and whether it speeds up thinking and walking speed. Data collected in the proposed studies may help identify a new treatment for LLD, which could have large public health ramifications given the prevalence, frequent treatment resistance, and chronicity characteristic of LLD. This project also will elucidate the neurobiology of slowing at molecular, structural, and functional levels of analysis, increasing our understanding of the interplay between these aging-associated processes and the pathophysiologic changes underlying late life neuropsychiatric disorders. Exploring patient characteristics that predict response to L-DOPA may provide useful information to guide differential therapeutics and develop personalized medicine for LLD.

Conditions

• Major Depressive Disorder
• Dysthymia
• Depression

Interventions

Type	Name	Description
DRUG	L-DOPA	We will be using generic sinemet 25/100 tablets in this study.
DRUG	Placebo Oral Tablet	25/100 placebo tablets

Timeline

• Start date: 2019-01-09
• Primary completion: 2021-09-08
• Completion: 2021-09-08
• First posted: 2018-12-03
• Last updated: 2023-05-22
• Results posted: 2023-05-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study