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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: Clinical Trial Phase 4 study, sponsored by New York State Psychiatric Institute.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
In this task participants decide whether to work harder for a larger reward (high number of finger presses with their pinky) or expend less energy (low number of presses with a dominant index finger) for a lesser reward, with lower rewards being $1 dollar and higher rewards ranging from $1.20 to $5. Participants receive information about the probability of winning on each trial regardless of their pick and one trial from each run is randomly picked for payout. The primary output on this task is
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 |
Why NCT04493320 stopped before completion
NCT04493320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04493320 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04493320's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 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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