Evidence map›Paper›PMID 41255293›Full record

ArticleInternational journal of methods in psychiatric research2025

The Ketamine Trial for Acute Suicidality (KETA): Study Protocol of a Double-Blind Randomized Placebo-Controlled Superiority Trial on Intranasal Racemic Ketamine Compared to the Active Placebo Intranasal Midazolam as Treatment for Acute Suicidality.

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

Abstract readClinical Trial Protocol
In one paragraph

Article in International journal of methods in psychiatric research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Jurriaan F M StrousDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0001-8767-2851
Gijs H J RoelandtDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Jens H van DalfsenDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Jeanine KamphuisDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Radboud M MarijnissenDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Robert A SchoeversDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.ORCID 0000-0003-0760-9866

Funding

ZonMw 537001004
6 · The paper itself

Abstract

backgroundSuicidality is a transdiagnostic entity in patients with and without psychiatric disorders. Ketamine is a novel treatment for treatment-resistant depression with favorable effects on related suicidality in this population. Little is known about the effects of ketamine on suicidality as a distinct phenomenon.

objectiveTo assess whether a dose of 75 mg intranasal (IN) ketamine reduces acute suicidality relative to a 4 mg intranasal dose of the active placebo midazolam, 180 min after administration. METHODS/

designA double-blind randomized placebo-controlled trial (N = 100) will assess the efficacy of fixed-dose IN racemic ketamine in patients presenting with acute suicidality, regardless of psychiatric diagnosis. Participants receive a single IN dose of either racemic ketamine (75 mg) or midazolam (4 mg) along with treatment as usual. The primary outcome is the reduction in suicidal ideation as measured by the Beck Scale for Suicide Ideation (BSSI) at 180 min. Secondary outcomes include depression severity with the Montgomery Åsberg Depression Rating Scale (MADRS) and tolerability with the Systematic Assessment for Treatment Emerging Effects (SAFTEE) as well as blood-based and neuroimaging markers. DISCUSSION: This study design considers key aspects such as patient selection, ketamine formulation, clinical management, and the follow-up time points. Potential risks, limitations, and future considerations are additionally discussed.

trial registrationEudraCT 2020-002905-24, registered 6 October 2021.

Indexed as

KetamineMidazolamOutcome Assessment, Health CareSuicidal IdeationAdministration, IntranasalAdolescentAdultDouble-Blind MethodEquivalence Trials as TopicFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicYoung AdultKetamineMidazolamketaminerandomized controlled trialsuicidality

Identifiers

PMID41255293
PMCPMC12627964

What Socratic holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.