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Single fixed-dose intranasal racemic ketamine treatment for the treatment of acute suicidality in a transdiagnostic patient population: Results of a pilot study.

Gijsbrecht H. J. Roelandt, Jurriaan F M Strous, Radboud M Marijnissen, Jeanine Kamphuis, Jens H van Dalfsen, Robert A Schoevers

Psychiatry Research March 1, 2026 DOI: 10.1016/j.psychres.2025.116909 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Pilot study Randomized Placebo-controlled Double-blind Open-label Peer reviewed
Sample size 12
Population Acutely suicidal patients in an emergency setting
Intervention Intranasal racemic ketamine
Dose 75 mg
Duration Single dose, assessed at 60 min, 180 min, and 1, 3, and 7 days post-treatment
Topics Ketamine Esketamine
Keywords Acute psychiatry Mood disorders Suicidality
Citations 1
Key points Intranasal ketamine reduced acute suicidality in some cases, but no definitive conclusions about efficacy can be drawn from this pilot study.

Abstract

Ketamine has been shown to decrease suicidality in patients with depression. However, little is known about tolerability and efficacy in heterogenous, acutely suicidal patients in emergency settings. This pilot study aimed to assess the feasibility, acceptability, and safety of generic intranasal racemic ketamine (75 mg) in the treatment of acute suicidality regardless of the underlying diagnosis, as preparation for a subsequent double-blind randomized placebo-controlled trial (RCT). From September 2021 to June 2022, 12 patients with acute suicidality were recruited. All received a single open-label dose of 75 mg intranasal racemic ketamine. Suicidality was assessed with the Beck Scale for Suicidal Ideation (BSSI), depression with the Montgomery-Åsberg Depression Rating Scale (MADRS), side effects with the Systematic Assessment for Treatment Emergent Effects (SAFTEE) and Clinician Administered Dissociative Symptom Scale (CADSS), and overall improvement with the Clinical Global Impression (CGI) at 60 min, 180 min, and at 1, 3, and 7 days post-treatment. The CADSS and SAFTEE were administered only at baseline, 60 and 180 min post intervention. Vital signs were monitored for the first 240 min post intervention. Optional blood sampling occurred at baseline and 180 min post-treatment, and Magnetic Resonance Imaging one day post intervention. Treatment was well-tolerated. We observed a downward trend in both BSSI and MADRS scores one day post treatment, though this effect declined by day seven. One patient developed ketamine misuse several weeks after participation. The treatment was generally feasible, well-tolerated and safe. Intranasal ketamine reduced acute suicidality in some cases but regarding efficacy, no definitive conclusions can be drawn from this pilot study. Amendments were made to the study protocol with extended follow-up time, investigation of drug liking and craving, less questionnaires and longer inclusion window.

Comparable studies

Other non-randomized and open-label trials on ketamine, most cited first.

Study Year Design Participants
Rapid Resolution of Suicidal Ideation After a Single Infusion of anN-Methyl-D-Aspartate Antagonist in Patients With Treatment-Resistant Major Depressive Disorder Subjects with DSM-IV-diagnosed treatment-resistant major depressive disorder 2010 Open-label trial n = 33
Intravenous arketamine for treatment-resistant depression: open-label pilot study Humans with treatment-resistant depression 2020 Open-label pilot trial n = 7
A Phase 2 Open Label Study of Efficacy, Safety, and Tolerability of SLS-002 (Intranasal Racemic Ketamine) in Adults with MDD at Imminent Risk of Suicide. Hospitalized patients with Major Depressive Disorder and acute suicidal ideation and... 2024 Open label study n = 17
Ketamine Psychedelic Therapy (KPT): A Review of the Results of Ten Years of Research Alcoholic patients 1997 Controlled clinical trial n = 211
Ketamine Safety and Tolerability in Clinical Trials for Treatment-Resistant Depression Participants with DSM-IV-defined major depressive disorder and treatment-resistant... 2014 Pooled analysis of three clinical trials n = 97

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