Status:
COMPLETED
Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Tinnitus
Eligibility:
All Genders
21-60 years
Phase:
PHASE2
Brief 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 di...
Detailed Description
Tinnitus has a prevalence of approximately 1 in 10 adults in the United States. Among those with tinnitus, 36% had nearly constant symptoms and almost 30% of those report that their tinnitus as a big ...
Eligibility Criteria
Inclusion
- Participant aged 21-60
- Tinnitus associated with at least mild sensori-neural hearing loss of at least 6 months duration
- Score at least 32 on the Tinnitus Handicap Inventory and a score of 5dB or greater on the minimum masking level
- Tinnitus not due to medical disease (other than sensorineural hearing loss)
- Score of at least 14 on the Hamilton Depression Rating Scales with a score of at least 2 on the Hamilton Anxiety Rating Scale (in the distressed group).
Exclusion
- DSM-V psychiatric disorders other than mild-moderate depression and anxiety, including substance use disorder.
- History of recreational ketamine use, recreational PCP use,exposure to ketamine as an anesthetic, or an adverse reaction to ketamine
- Currently taking psychotropic medication (e.g.antipsychotics, antidepressants, benzodiazepines)
- Presence or positive history of significant medical or neurological illness, including high blood pressure (SBP \>140, DBP \> 90), cardiac illness, abnormality on EKG, head injury.
- Pregnancy, abortion, or lack of effective birth control during 15 days before the scan
- Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the
- Medicinal patch that cannot be removed for the scans.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03336398
Start Date
September 1 2019
End Date
July 1 2024
Last Update
July 3 2024
Active Locations (1)
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1
1051 Riverside Drive
New York, New York, United States, 10032