Citation

Liu H, Lan X, Wang C, Zhang F, Fu L, Li W, Ye Y, Hu Z, Chao Z, Ning Y, Zhou Y. BMC Psychiatry 2022; 22(1): 744.

Copyright

(Copyright © 2022, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s12888-022-04388-y

PMID

36451150

PMCID

PMC9710171

Abstract

BACKGROUND: Major depressive disorder (MDD) is a high risk factor for suicide, with up to 20% of MDD patients attempting suicide during their lifetime. Current treatments for MDD are slow onset of action, low efficiency, and the inability to control suicidal behaviors quickly and effectively. Intravenous ketamine has been shown to have a rapid but transient antidepressant effect, but there is still lack evidence on the efficacy and safety of intravenous esketamine in reducing suicidal ideation and depressive symptoms in MDD patients with suicidal ideation. We designed a study to investigate the effect of short-term repeated intravenous infusion of esketamine three times in MDD patients with suicidal ideation.

METHODS: This study features a randomized, double-blind, placebo-controlled trial (RCT) comparing short-term repeated intravenous infusions of esketamine with placebo as a supplement to conventional antidepressants with an intervention period of 6 days and one infusion every other day, followed by 4 weeks of follow-up. These methods support the examination of the efficacy, safety, tolerability, and mechanism of action of short-term repeated intravenous infusions of esketamine in MDD patients with suicidal ideation.

DISCUSSION: This is the first RCT to explore the efficacy and safety of short-term repeated infusion of esketamine on suicidal ideation and depressive symptoms in MDD patients with suicidal ideation. If proven effective and tolerated, it will provide evidence for rapid and effective treatment of suicidal ideation and depressive symptoms in MDD individuals with suicidal ideation. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2000041232. Registered 22 December 2020.

Language: en

Keywords

Humans; Suicide; Randomized Controlled Trials as Topic; Suicidal Ideation; Major depressive disorder; *Suicide; Clinical trial; Esketamine; *Depressive Disorder, Major/drug therapy; *Ketamine/adverse effects