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Search / Trial NCT03336398

Investigation of the NMDA Antagonist Ketamine as a Treatment for Tinnitus

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Nov 6, 2017

Trial Information

Current as of May 02, 2025

Completed

Keywords

ClinConnect Summary

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 or a very big problem. Currently there are few effective treatments for tinnitus, and no approved medications. Cognitive behavioral and retraining therapy provide some relief, but many patients fail to respond.

Animal research and human studies indicate that maladaptive plasticity plays a role in tinnitus, which involves glutamatergic signaling largely at the NMDA and AMPA receptors. Additiona...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About New York State Psychiatric Institute

The New York State Psychiatric Institute (NYSPI) is a leading research organization dedicated to advancing the understanding and treatment of mental health disorders. Affiliated with Columbia University, NYSPI integrates clinical research with cutting-edge scientific inquiry to develop innovative therapeutic strategies and improve patient care. With a focus on a wide range of psychiatric conditions, NYSPI conducts clinical trials that aim to translate findings from laboratory research into effective interventions, enhancing the quality of life for individuals affected by mental illness. Committed to ethical research practices and collaboration, NYSPI plays a pivotal role in shaping the future of psychiatric care through rigorous scientific exploration and community engagement.

Locations

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

Diana Martinez

Principal Investigator

NYSPI/Columbia University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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