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NCT04091971 · ClinicalTrials.gov registry record · Phase 4
Ketamine Treatment Effects on Synaptic Plasticity in Depression
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 9
- Enrollment target
NCT04091971 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 9 participants.
The verdict
NCT04091971, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 9 participants
- Enrollment target
Study Summary
Depression is the leading cause of disability globally (1, 2). One-third to one-half of patients suffering from major depressive disorder (MDD) do not achieve remission even after multiple antidepressant trials (3). Ketamine is a commonly-used FDA-approved anesthetic medication that at subanesthetic doses leads to rapid antidepressant and anti-suicidal ideation effects in hours, rather than weeks, following administration. Despite these promising findings, a key limitation of ketamine treatment is that it only yields an antidepressant response in approximately 50% of those treated. The goal of this project is to A) elucidate ketamine's mechanism of action and B) identify biomarkers predicting treatment outcome to ketamine which could be used to match patients to treatment based on the likelihood of effectiveness at the individual level. Data from animal models suggests that ketamine acts by enhancing the connections between neurons through a process known as synaptic plasticity (4-7), and that these biological changes are responsible for the sustained behavioral effects of ketamine (8). A newly available tool allows us to image the density of these synaptic connections in the living brain using PET (positron emission tomography) imaging with a radiotracer called \[11C\]UCB-J, which is a marker of synaptic density. We propose to directly quantify synaptic density in depressed patients before and after a course of ketamine, to examine changes in density following treatment. In exploratory analyses, we will examine synaptic density as a mediator of the sustained antidepressant effects of ketamine and as a predictor of treatment outcome. To study these questions, we will quantify synaptic density using PET imaging before and after a course of 4 sequential intravenous infusions of ketamine administered over a two week period. Study participation involves an inpatient stay of approximately three weeks at the New York State Psychiatric Institute at no cost.
Interventions
- DRUG Ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2020-10-09 |
| Est. Completion | 2022-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04091971
The ClinicalTrials.gov registry entry for NCT04091971 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 9 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 1 intervention - of which Ketamine is the first listed.
NCT04091971 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04091971 about?
NCT04091971 is a clinical study titled "Ketamine Treatment Effects on Synaptic Plasticity in Depression". Depression is the leading cause of disability globally (1, 2). One-third to one-half of patients suffering from major depressive disorder (MDD) do not achieve remission even after multiple antidepressant trials (3). Ketamine is a commonly-used FDA-approved anesthetic medication that at subanesthetic...
What is the current status of trial NCT04091971?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 9 participants. The study started on 2020-10-09. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT04091971?
The interventions under investigation include: Ketamine (DRUG).
Who is sponsoring clinical trial NCT04091971?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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