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NCT03761030 · ClinicalTrials.gov registry record · Phase 4
L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 51
- Enrollment target
NCT03761030: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT03761030 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 51 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03761030, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 51 participants
- Enrollment target
Study Summary
Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional problems in patients with LLD. Similarly, decreased walking speed is associated with depression and carries additional risk for falls, hospitalization, and death. Available evidence suggests that declining functionality in the brain's dopamine system contributes to age-related cognitive and motor slowing. The central hypothesis of this study is that by enhancing dopamine functioning in the brain and improving cognitive and motor slowing, administration of carbidopa/levodopa (L-DOPA) will improve depressive symptoms in older adults.
Primary Outcome
The Hamilton Rating Scale for Depression (HRSD) is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. Because the full sample was not enrolled and the results are considered unreliable, no statistical analysis was performed other than calculating
Interventions
- DRUG Placebo Oral Tablet
- DRUG L-DOPA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-01-09 |
| Est. Completion | 2021-09-08 |
| Phase | Phase 4 |
Why NCT03761030 stopped before completion
NCT03761030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03761030 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03761030 about?
NCT03761030 is a clinical study titled "L-DOPA vs. Placebo for Depression and Psychomotor Slowing in Older Adults". Individuals with Late Life Depression (LLD) often have cognitive problems, particularly problems with memory, attention, and problem solving, all of which contribute to antidepressant non-response. Our group and others have shown that decreased thinking speed is the central cause of functional probl...
What is the current status of trial NCT03761030?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 51 participants. The study started on 2019-01-09. Estimated completion is 2021-09-08.
What interventions are being tested in trial NCT03761030?
The interventions under investigation include: Placebo Oral Tablet (DRUG), L-DOPA (DRUG).
Who is sponsoring clinical trial NCT03761030?
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 NCT03761030's enrollment target sits among peer trials
51 1249th of 2000 higher than 746 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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