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TerminatedPhase 3Results posted

Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

NCT04260607 · Naval Medical Center Camp Lejeune

Closed to entry
Status
Not accepting participants
Phase 3
Phase
1
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

Current treatment for acutely suicidal patients are limited to hospitalization, psychotherapy, electro-convulsant therapy, or a combination of the aforementioned. However, this has added to the national boarding problem. Long term pharmacologic treatment for suicidal behaviors and mood stabilization has been studied in specific populations. In these populations, the decreases in suicidal ideation results from stabilization of the underlying psychiatric illness. Ketamine is most commonly used as an anesthetic with analgesic properties. It has been used off-label for pain management, procedural sedation, status epilepticus, and treatment resistant depression. It has been safely administered intravenously and well tolerated for chronic Post Traumatic Stress Disorder. It increases norepinephrine, dopamine, and serotonin through adrenergic neuron stimulation and prevention of catecholamine uptake. There is a strong corollary between stress and the development of depression and suicidal behaviors. It is proposed that the use of low dose intravenous ketamine may have benefit on the suicidal ideation of patients presenting to the Emergency Department.

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

  • Suicidal Severity - Clinical Efficacy

    Measured over 4 hour+/1 after infusion completion (performed for placebo and drug arms)

  • Suicidal Severity - Clinical Efficacy

    Measured over 24-36 hours after infusion completion (performed for placebo and drug arms)

  • Suicidal Severity - Efficacy at 1 Week

    Measured over 1week+/-1 day after infusion completion (performed for placebo and drug arms)

  • Depression Symptoms - Clinical Efficacy

    Measured over 4 hours +/-1 after infusion completion (Performed for placebo and drug arms)

  • Depression Symptoms - Clinical Efficacy

    Measured over 24-46 hours after infusion completion (Performed for placebo and drug arms)

  • Depression Symptoms - Efficacy at 1 Week

    Measured over 1 week +/-1 day after infusion completion, performed for placebo and drug arms

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 to 89 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Subject Inclusion and Selection Criteria 1. Patient demographics will consist of Active, Reserve, or retired military personnel or their dependents. Subjects must meet the following inclusion criteria: 2. Adult (18 to 89 years old) 3. Present with active SI 4. Deemed to being admitted to inpatient psychiatric unit Subject Exclusion Criteria: 1. Age \< 18 years old or \> 89 years old 2. Currently presenting with psychosis as determined by mental health consultant 3. Have a history of Cognitive disorder that would impair understanding of consent 4. Have a personal/family history of Schizophrenia 5. Currently pregnant or nursing 6. Serious and unstable medical condition/problems 7. Inability to medically clear 8. Non-English Speakers 9. Civilian Humanitarians 10. Have previously enrolled in this study

Where

1 study site

FacilityCityRegionCountry
Naval Medical Center Camp LejeuneMarine Corps Base Camp LejeuneNorth CarolinaUnited States

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, which is also where the most current version of everything above lives.

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NCT04260607 on ClinicalTrials.gov →

Last updated in the registry 2025-05-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in