Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing (NCT04650217) | Clinical Trial Compass
TerminatedPhase 4
Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing
Stopped: Study terminated by sponsor (NIMH)
United States1 participantsStarted 2021-10-07
Plain-language 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.
Who can participate
Age range
60 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged greater than or equal to 60 years
. Diagnostic and Statistical Manual (DSM) 5 MDD, Dysthymia, or Depression Not Otherwise Specified (NOS)
. Hamilton Rating Scale for Depression (HRSD) greater than or equal to 18
. Decreased processing speed (defined as 1 SD below age-adjusted norms on the Digit Symbol Test) or decreased gait speed (defined as average walking speed over 15' course less than 1m/s)
. Willing to and capable of providing informed consent and complying with study procedures
Exclusion criteria
. Substance abuse or dependence (excluding Tobacco Use Disorder) within the past 12 months
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of psychosis, psychotic disorder, mania, or bipolar disorder
. Probable Alzheimer's Disease, Vascular Dementia, or Parkinson's disease
. Mini Mental Status Examination (MMSE) less than or equal to 24
. HRSD suicide item greater than 2 or Clinical Global Impressions (CGI) Severity score of 7 at baseline
. Current or recent (within the past 4 weeks) treatment with antidepressants, antipsychotics, or mood stabilizers
. History of allergy, hypersensitivity reaction, or severe intolerance to levodopa/carbidopa
. Any physical or intellectual disability adversely affecting ability to complete assessments, including physical inability to perform treadmill testing and exercise protocol