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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 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04650217
The ClinicalTrials.gov registry entry for NCT04650217 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT04650217 reports 0 study locations.
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.
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