Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

Brief Summary

This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode in Major Depressive Disorder (MDD) or Bipolar Disorder (BD) with or without comorbid recent abuse of alcohol.

Intervention / Treatment

  • Drug: intranasal ketamine
  • Drug: Placebo

Condition or Disease

  • Suicidal Ideation
  • Depression
  • Alcohol Abuse

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 21 Years to 60 Years   (Adult)
Enrollment: 50 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: May 01, 2018
Primary Completion: Oct 30, 2020
Completion Date: Dec 25, 2020
Study First Posted: May 29, 2018
Results First Posted: Aug 31, 2020
Last Updated: Apr 24, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Clinicians have a limited ability to predict imminent suicidal behavior and efficacious treatments are not available to treat suicidal patients. Thus, Rapid-acting treatments for suicidal individuals are truly needed. This project aims to evaluate the potential rapid and sustained antisuicidal and antidepressant effects of a single intranasal dose of ketamine in inpatients during a mood episode (in Major Depressive Disorder, MDD or Bipolar Disorder, BD) with or without comorbid recent abuse of alcohol. These results will elucidate the antisuicidal effects of ketamine using the intranasal route along with the identification of associated mediators or moderators; this approach has the potential for enormous public health impact.

Eligibility Criteria

Sex: All
Minimum Age: 21
Maximum Age: 60

This clinical trial is recruiting

Are you interested in participating in this trial or others? We'd love to help.

More Details

NCT Number: NCT03539887
Other IDs: HSC-MS-17-0903
Study URL: https://ClinicalTrials.gov/show/NCT03539887
Last updated: Jun 17, 2022