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NCT03336398 · ClinicalTrials.gov registry record · Phase 2
Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT03336398 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 42 participants.
The verdict
NCT03336398, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
Tinnitus, or ringing in the ears, is a very common problem that often accompanies hearing loss. It affects up to 1 in 10 adults, and about 30% of people who experience chronic tinnitus find it very distressing. In these patients, symptoms of depression and anxiety often accompany tinnitus and there are no approved treatments. Clinical trials are ongoing to test a glutamate NMDA receptor antagonist (called esketamine), which is injected into the inner ear. However, the preliminary results with this medication show that it only works for tinnitus that results from acute injury. It does not treat tinnitus resulting from progressive hearing loss. Research in humans and animals suggest that the neurotransmitters glutamate and GABA are important in the development and maintenance of tinnitus. This data shows that over-activation of the NMDA receptor and a decrease in GABA signaling in the brain play a crucial role. Previous studies show that ketamine, which an antagonist at the NMDA receptor, increases GABA levels in the brain in participants with depression. Thus, in this experiment, this study will test the effect of ketamine on tinnitus, since it blocks the NMDA glutamate receptor and increase GABA levels. Two groups of participants will be included in this study: those who experience distress (symptoms of anxiety or depression) with tinnitus and those who have tinnitus but do not experience distress. Each participant will receive both ketamine and placebo on different days. Magnetic Resonance Spectroscopy (MRS) scans will be
Interventions
- DRUG Ketamine Hydrochloride in saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2024-07-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03336398
The ClinicalTrials.gov registry entry for NCT03336398 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 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 Hydrochloride in saline is the first listed.
NCT03336398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03336398 about?
NCT03336398 is a clinical study titled "Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus". Tinnitus, or ringing in the ears, is a very common problem that often accompanies hearing loss. It affects up to 1 in 10 adults, and about 30% of people who experience chronic tinnitus find it very distressing. In these patients, symptoms of depression and anxiety often accompany tinnitus and there ...
What is the current status of trial NCT03336398?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-09-01. Estimated completion is 2024-07-01.
What interventions are being tested in trial NCT03336398?
The interventions under investigation include: Ketamine Hydrochloride in saline (DRUG).
Who is sponsoring clinical trial NCT03336398?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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