WithdrawnPhase 3

A Study to Decrease Suicidal Thinking Using Ketamine

NCT02418702 · United States Naval Medical Center, San Diego

Closed to entry

Status

Not accepting participants

Phase 3

Phase

—

Target enrolment

Study sites

1 US states

What it is testing

Summary

Depression treatment typically is slow acting. Patients presenting with acute suicidality have few immediate treatment options. However, sub-anesthetic doses of ketamine have been now widely tested as a rapid-acting treatment for depression. Gregory Larkin et al at Yale showed this could be applied to suicidal patients, with 14 of 15 participants showing remission of suicidal thinking within 40 min of the administration of ketamine, with 13 showing lasting remission out to 10 days. No serious side effects were reported. This project proposes to conduct a randomized, placebo-controlled trial of this, same intervention in military patients recently hospitalized for suicidal thinking. After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine or placebo. Their suicidal thinking, depression, and other symptoms would be monitored acutely for 240 min after drug infusion, and the for lasting changes the next day, at hospital discharge, 2 weeks, and 10 weeks. Potential adverse events will be monitored via the electronic medical record for up to a year.

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

Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Measured over baseline and 240 minutes
Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Measured over baseline and 2 weeks
Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Measured over baseline and 10 weeks

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 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * Voluntarily, psychiatrically hospitalized at NMCSD within the last 12 hours for suicidal thinking * BSS greater than 4 * BHS greater than 8 * BDI greater than 19 * Ability to give informed consent * Active duty military status * Verified negative pregnancy test for females Exclusion Criteria: * Psychosis or bipolar disorder * Pregnancy * Involuntary status on presentation to the ED * Positive for illicit drugs of abuse * Blood alcohol level greater than zero * Previous enrollees in this treatment protocol will be excluded from repeat participation * Any patient brought for command directed psychiatric evaluation * Specific contraindication to the use of ketamine are as follows and under such circumstances or conditions, personnel with the following should be excluded from participation in this study: A) patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, congestive heart failure (CHF), a recent history of head or eye injury, or angina B) all personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being C) patients currently utilizing the following medications: conivaptan, dasatinib, peginterferon alfa-2b, quazepam, tocilizumab

Where

1 study site

Facility	City	Region	Country
Naval Medical Center San Diego	San Diego	California	United 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.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT02418702 on ClinicalTrials.gov →

Last updated in the registry 2019-09-03. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

Recruiting in

California115

All 2 trials from United States Naval Medical Center, San Diego →