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 range60 Years – 100 Years
SexALL
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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
✕. 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