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Not yet recruitingPhase 2

Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay

NCT07888933 · University of Sao Paulo

Closed to entry
Status
Not accepting participants
Phase 2
Phase
106
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

This randomized, double-blind, active placebo-controlled superiority trial will evaluate whether intravenous esketamine reduces time to psychiatric hospital discharge in adults hospitalized because of acute suicide risk. A total of 106 participants will be randomized in a 1:1 ratio to receive intravenous esketamine or midazolam as an active placebo. Participants assigned to esketamine will receive eight 40-minute intravenous infusions at a dose of 0.5 mg/kg administered twice weekly. The primary outcome is time from the first study infusion to psychiatric hospital discharge. Secondary outcomes include suicidal ideation and behavior, depressive symptoms, psychological pain, hopelessness, global clinical improvement, safety, tolerability, dissociative symptoms, and healthcare costs. Exploratory analyses will investigate peripheral inflammatory markers, BDNF, and polygenic risk scores as potential predictors or mediators of treatment response. Clinical follow-up will continue through Week 12.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Time to Psychiatric Hospital Discharge

    Measured over From the first study infusion until discharge from the index psychiatric hospitalization, assessed up to 6 months.

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Age ≥18 years. * Psychiatric hospitalization because of suicide risk. * Acute suicidal ideation, defined as a Scale for Suicide Ideation (SSI) score \>3. * Ability to understand the study procedures and provide written informed consent. * Willingness to participate in the study. Exclusion Criteria: * Current diagnosis of schizophrenia or another psychotic disorder. * Active substance use disorder within the previous 6 months, except caffeine or nicotine. * Known contraindication to esketamine, including severe hypertension, previous stroke, intracranial hypertension, porphyria, or known hypersensitivity to the study drug. * Pregnancy or breastfeeding. * Unstable medical condition or clinically relevant cardiovascular risk. * Participation in another clinical trial within the previous 3 months.

Where

1 study site

FacilityCityRegionCountry
Institute of Psychiatry, Hospital das Clínicas, University of São Paulo Medical SchoolSão PauloSão PauloBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

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NCT07888933 on ClinicalTrials.gov →

Last updated in the registry 2026-10-22. Registry records change; this page reflects the data build of 2026-10-30.

Related

Where this trial sits