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TerminatedPhase 1

Subanesthetic IV Bolus Ketamine in the Treatment of Acute Depression

NCT02378415 · United States Naval Medical Center, San Diego

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The objective of this double-blinded placebo-controlled pilot study is to determine whether a single sub-anesthetic rapid IV bolus dose of ketamine administered to acutely depressed patients with or without suicidality has a significant rapid antidepressant effect in the acutely depressed population. The study will pursue as a primary outcome measure whether a significant reduction in depressive symptoms, as assessed by the BSS and BHS, occurs shortly after administration of ketamine at 40, 80, 120, and 240 minutes. A secondary outcome measure will be assessed to determine whether this single infusion of ketamine has a sustained reduction in depressive symptoms within 2-weeks post-infusion with a reduction in BDI score. Suicidal ideation will also be assessed for determination of any reduction and sustained reduction post infusion by assessment of the Beck Suicidal Ideation Scale (BSS), Beck Hopelessness Scale (BHS) and Beck Depression Inventory (BDI) at similar intervals.

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

  • Suicidality

    Measured over Baseline

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
Accepted
Healthy volunteers
Inclusion Criteria: 1. BSS greater than 4 2. BHS greater than 8 3. BDI greater than 19 4. Ability to give informed consent. 5. Active Duty military status. 6. Verified negative qualitative pregnancy test. 7. All participants must be accepted for psychiatric admission to the hospital PRIOR to consideration for enrollment in this study. Exclusion Criteria: 1. Psychosis or Bipolar Disorder. 2. Pregnancy 3. Involuntary Status on presentation to the ED. 4. UDS positive for illicit drugs of abuse. 5. Blood Alcohol level greater than zero. 6. Previous enrollees in this treatment protocol will be excluded from repeat participation. 7. Any patient brought for command directed psychiatric evaluation. 8. Specific contraindications 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: 1. Patients with elevated intracranial pressure, uncontrolled hypertension, coronary artery disease, aneurysms, thyrotoxicosis, CHF, a recent history of head or eye injury, or angina. 2. All personnel in whom a significant elevation of blood pressure would constitute a serious hazard to their overall health and well-being. 3. Patients currently utilizing the following medications: conivaptan, Disatinib, peginterferon alfa-2b, quazepam, tocilizumab

Where

1 study site

FacilityCityRegionCountry
Naval Medical Center San DiegoSan DiegoCaliforniaUnited 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.

NCT02378415 on ClinicalTrials.gov →

Last updated in the registry 2015-03-04. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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