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NCT04650217 · ClinicalTrials.gov registry record · Phase 4
Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT04650217: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT04650217 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04650217, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
The MADRS is a standard rater-administered measure of depression severity that will be used to measure changes in depressive symptoms during the study. The total MADRS score ranges from a minimum score of 0 to a maximum score of 60. Higher scores indicate more severe depression.
Interventions
- DRUG Placebo
- BEHAVIORAL Control
- BEHAVIORAL Exercise training
- DRUG Carbidopa/levodopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2021-12-31 |
| Phase | Phase 4 |
Why NCT04650217 stopped before completion
NCT04650217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04650217 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04650217 about?
NCT04650217 is a clinical study titled "Levodopa and Exercise for Older Adults With Depression and Psychomotor Slowing". 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 adult...
What is the current status of trial NCT04650217?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2021-10-07. Estimated completion is 2021-12-31.
What interventions are being tested in trial NCT04650217?
The interventions under investigation include: Placebo (DRUG), Control (BEHAVIORAL), Exercise training (BEHAVIORAL), Carbidopa/levodopa (DRUG).
Who is sponsoring clinical trial NCT04650217?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04650217's enrollment target sits among peer trials
1 2000th of 2000 the lowest of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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