A Study to Decrease Suicidal Thinking Using Ketamine

A Randomized Controlled Trial to Decrease Suicidal Thinking Using Ketamine

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.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

Patients presenting for acute suicidality have few immediate treatment options to alleviate their suffering aside from psychiatric hospitalization for safety assurance. Therapy and psychiatry medication may decrease depression over time, but this does little to improve depression and suicidal thinking in the short term. Preliminary data from a recent study by Larkin et al at Yale University showed evidence to support a promising novel treatment modality with rapid effects on suicidal ideation for up to 10 days post infusion through the use of a single sub-anesthetic rapid intravenous bolus dose of ketamine (0.2-mg/kg) administered in the acute Emergency Department setting. This study showed favorable evidence to support further investigation into the use of a single sub-anesthetic bolus dose of ketamine in acutely depressed and/or suicidal patients in the emergency room setting. Based on the success of this study, Naval Medical Center San Diego (NMCSD) started the previously mentioned, small, unfunded randomized, placebo-controlled trial of this ketamine protocol for patients who were pending psychiatric hospitalization because of suicidal thinking. Data collection was highly flawed, but unpublished, preliminary results show that the ketamine treatment resulted in significant decreased in suicidal thinking.

Of note, there were no adverse events associated with the ketamine administration. Although the infusion was done in an Emergency Department (ED) setting, the patients were seated in clinic chairs, and required no additional monitoring or intervention beyond what could be provided in any clinic our psychiatric hospital setting. It is the intent of the project to expand on our unfunded trial, allowing us to treat a wider range of participants who come in to the psychiatric ward because of suicidal thinking. This study is being pursued in the context that existing therapies for major depression have a lag of onset of action of several weeks, resulting in an increased risk of possible and considerable morbidity and possibly mortality through suicide. This study would explore the efficacy of Ketamine's (a N-Methyl-D-aspartate (NMDA) receptor antagonist) rapid and potentially long-lasting antidepressant effects in a suicidal population. The Investigators hope to gather data that could potentially impact treatment practices in the military setting for acutely depressed patients. This may potentially shorten, delay, or even forgo admissions to the psychiatric ward in the future, as well as potentially reducing the long term suicidality.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • San Diego, California, United States, 92134
        • Naval Medical Center San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.2mg/kg ketamine
After being assessed, and giving informed consent, participants would receive 0.2mg/kg ketamine. 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.
20 patients will randomly be assigned 0.2 mg/kg of Ketamine
Other Names:
  • Ketamine
Placebo Comparator: placebo
After being assessed, and giving informed consent, participants would receive a placebo. Symptoms will be monitored.
20 patients will randomly be assigned a placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI)
Time Frame: baseline and 240 minutes
measure whether a significant reduction in depressive symptoms, as assessed by the BSS, BHS, and BDI occurs shortly after administration of ketamine
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)
Time Frame: baseline and 2 weeks
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)
Time Frame: baseline and 10 weeks
baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 1 day post-infusion
single bolus of ketamine's effect on sustained reduction of symptoms
1 day post-infusion
Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 2 weeks post-infusion
2 weeks post-infusion
Reduction in suicidal thinking measured by BSS, BHS, and BDI
Time Frame: 10 weeks post-infusion
10 weeks post-infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marc A Capobianco, United States Naval Medical Center, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2016

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 16, 2015

Study Record Updates

Last Update Posted (Actual)

September 3, 2019

Last Update Submitted That Met QC Criteria

August 29, 2019

Last Verified

August 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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