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

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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

ABSTRACT

Objective: This study aimed to investigate the effects of intranasal (IN) racemic (R,S)-ketamine on antisuicidal and antidepressant outcomes in patients with unipolar and bipolar depression, with and without comorbid alcohol use disorder (AUD).

Methods: The trial, conducted from May 2018 to January 2022, involved unmedicated inpatients meeting criteria for a current major depressive episode, with suicidal ideation and past attempt. Patients with and without comorbid AUD were enrolled. The primary outcome measure was change in Scale for Suicide Ideation score, and the secondary outcome measure was change in Montgomery-Åsberg Depression Rating Scale score.

Results: The study found that IN ketamine induced rapid antidepressant effects compared to placebo, with a trend toward superior improvement in suicidality observed in participants with comorbid AUD. The treatment was well tolerated.

Conclusion: IN ketamine showed rapid antidepressant effects compared to placebo but did not significantly alter suicidal ideation scores. The study suggests the need for continued investigation with IN ketamine as a practical alternative to current formulations.

Trial Registration: ClinicalTrials.gov identifier: NCT03539887.

PMID:38696221 | DOI:10.4088/JCP.23m14974

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