CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 33 enrolled
Drug / intervention
Intranasal ketamine +1 moredrug
Likely dose
Intranasal ketamine 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03539887
NCT03539887Phase 3Completed
CompareCT.gov

A Randomized, Double-Blind, Placebo-Controlled Trial of the Rapid Antisuicidal Effects of Intranasal Ketamine in Comorbid Depression and Alcohol Abuse

The University of Texas Health Science Center, Houston·interventional·Posted May 29, 2018·Updated Mar 1, 2023

In Brief

A Phase 3 clinical trial evaluating Intranasal ketamine and Placebo for Suicidal Ideation and 2 related conditions. Completed, enrolled 33 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSuicidal Ideation, Depression, Alcohol Abuse
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 29, 2018
Enrollment StartMay 1, 2018
Primary CompletionJan 15, 2022
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 8.1 years ago

Interventions

Intranasal ketaminedrug

Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).

Placebodrug

Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.