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

Phase 3 Completed 33 enrolled The University of Texas Health Science Center, Houston

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2018-05-01
Primary completion: 2022-01-15
Completion: 2022-01-15

Outcome

Missed primary endpoint

paper No significant group × time effect was noted for SI (F = 1.1, P = .36). PMID 38696221 ↗

Publications

Jones GH, Vecera CM, Ruiz AC, Wu HE, McInturff SI, Orejarena MJ, Smith KA, Soares JC, Zarate CA, Lane SD, Machado-Vieira R. A Randomized, Double-Blind, Placebo-Controlled Pilot Trial of the Acute Antisuicidal and Antidepressant Effects of Intranasal (R,S)-Ketamine in Severe Unipolar and Bipolar Depression With and Without Comorbid Alcohol Use Disorder. J Clin Psychiatry. 2024 Apr 24;85(2):23m14974. doi: 10.4088/JCP.23m14974.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ketamine	Small molecule	50 mg	Intranasal