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NCT04493320 · ClinicalTrials.gov registry record · Phase 4
1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT04493320 is a Phase 4 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 5 participants.
The verdict
NCT04493320, a Phase 4 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study Summary
Growing evidence suggests that dopamine contributes to key cognitive, emotional, and motor functions across the lifespan. In Late-Life Depression (LLD), dysfunction in these areas is common, predicts poor outcomes, and manifests as difficulties in motivation and effort along with cognitive and gait impairment. While studies of dopamine function in early and midlife depression primarily focus on individuals' ability to feel pleasure and respond to rewards, they often exclude the cognitive and physical function domains relevant for older adults despite a recognized decline in dopamine function with normal aging. The objectives of this collaborative R01 proposal between Columbia University/New York State Psychiatric Institute and Vanderbilt University Medical Center are to: 1) characterize dopaminergic dysfunction in LLD across cognitive, emotional, and motor domains at several levels of analysis (cellular Positron Emission Tomography \[PET\], circuit Magnetic Resonance Imaging \[MRI\], and behavioral / self-report); and 2) examine the responsivity of dopamine-related circuits and behavior to stimulation with carbidopa/levodopa (L-DOPA).
Interventions
- DRUG Placebo
- DRUG Carbidopa/levodopa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2021-10-27 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04493320
The ClinicalTrials.gov registry entry for NCT04493320 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 5 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 2 interventions - of which Placebo is the first listed.
NCT04493320 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04493320 about?
NCT04493320 is a clinical study titled "1/2-Dopaminergic Dysfunction in Late-Life Depression (The D3 Study)". Growing evidence suggests that dopamine contributes to key cognitive, emotional, and motor functions across the lifespan. In Late-Life Depression (LLD), dysfunction in these areas is common, predicts poor outcomes, and manifests as difficulties in motivation and effort along with cognitive and gait ...
What is the current status of trial NCT04493320?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2021-02-10. Estimated completion is 2021-10-27.
What interventions are being tested in trial NCT04493320?
The interventions under investigation include: Placebo (DRUG), Carbidopa/levodopa (DRUG).
Who is sponsoring clinical trial NCT04493320?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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