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NCT04260607 · ClinicalTrials.gov registry record · Phase 3

Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

A Phase 3 study, sponsored by Naval Medical Center Camp Lejeune.

Terminated
Registry status
Phase 3
Development phase
1
Enrollment target

NCT04260607: Clinical Trial Phase 3 study, sponsored by Naval Medical Center Camp Lejeune.

NCT04260607 is a Phase 3 study that was terminated before completion, run by Naval Medical Center Camp Lejeune. The registered enrollment target is 1 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04260607, a Phase 3 study, was terminated before completion, sponsored by Naval Medical Center Camp Lejeune.

TERMINATED
Registry status
Phase 3
Development phase
1 participants
Enrollment target

Study 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.

Primary Outcome

Suicidal severity is measured by the total score on the Beck Scale for Suicide Ideation (BSS or BSSI). The BSS is a 21-item scale, where each item contains a group of statements that are rated from 0 to 2. Items 1 to 5 comprise a screening subscale. If the patient scores 0 in total on items 4 and 5, items 6 to 19 are skipped. Item 21 is only asked if the patient has attempted suicide at least once. The screening subscale can range from 0 to 10 points, whereas the total score can range from 0 to

Interventions

  • DRUG Normal saline
  • DRUG Ketamine Hydrochloride

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2020-01-14
Est. Completion 2022-02-16
Phase Phase 3

Why NCT04260607 stopped before completion

NCT04260607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 2 interventions - of which Normal saline is the first listed.

NCT04260607 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04260607 about?

NCT04260607 is a clinical study titled "Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department". 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...

What is the current status of trial NCT04260607?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2020-01-14. Estimated completion is 2022-02-16.

What interventions are being tested in trial NCT04260607?

The interventions under investigation include: Normal saline (DRUG), Ketamine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT04260607?

This trial is sponsored by Naval Medical Center Camp Lejeune, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04260607's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04260607, the US trial registry maintained by the National Library of Medicine. NCT04260607 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.