drugset / Trial / NCT04650217

Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing

NCT04650217 ↗

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this new research study, 80 adults aged \> 60 years with a significant depressive disorder and slowed processing and/or gait speed will be randomized to receive levodopa (L-DOPA; which the Candidate has previously shown to increase psychomotor speed and decrease depressive symptoms in older adults), aerobic exercise (itself an effective antidepressant treatment as monotherapy), or their combination in a 2x2 design incorporating placebo and a stretching/toning control. Participants will be evaluated before and after this 12-week duration study across cognitive domains, psychiatric symptoms, gait kinematics and mobility, and task-based magnetic resonance imaging (MRI) focused on effort-based decision making and reward processing. Data from this study will contribute toward the development of improved treatment and prevention strategies to maximize the functioning and active healthspan of older adults with neuropsychiatric disorders.

Timeline

Start
2021-10-07
Primary completion
2021-12-31
Completion
2021-12-31

Outcome

Outcome not reported

Stopped: “Study terminated by sponsor (NIMH)”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carbidopa/levodopa Unknown 450 mg —

Indications