A Study to Decrease Suicidal Thinking Using Ketamine

Brief 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.

Intervention / Treatment

  • 0.2 mg/kg ketamine (DRUG)
    20 patients will randomly be assigned 0.2 mg/kg of Ketamine
  • Placebo (OTHER)
    20 patients will randomly be assigned a placebo

Condition or Disease

  • Depression
  • Suicide

Phase

  • Phase 3
  • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: 18 Years to 65 Years
    Enrollment: 0 (ACTUAL)
    Funded by: U.S. Fed
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Aug 01, 2016 ESTIMATED
    Primary Completion: Aug 01, 2016 ESTIMATED
    Completion Date: Aug 01, 2017 ESTIMATED
    Study First Posted: Apr 16, 2015 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Aug 29, 2019

    Sponsors / Collaborators

    Lead sponsor is responsible party
    Responsible Party: N/A

    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.

    Participant Groups

    • 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.

    • After being assessed, and giving informed consent, participants would receive a placebo. Symptoms will be monitored.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 65
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    Primary Outcomes
    • measure whether a significant reduction in depressive symptoms, as assessed by the BSS, BHS, and BDI occurs shortly after administration of ketamine

    • Change in baseline in depressive symptoms measured by Beck Scale for Suicide ideation (BSS), Beck Hopelessness Scale (BHS), and Beck Depression Index (BDI) 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) baseline and 10 weeks
    Secondary Outcomes
    • single bolus of ketamine's effect on sustained reduction of symptoms

    • Reduction in suicidal thinking measured by BSS, BHS, and BDI 2 weeks post-infusion
    • Reduction in suicidal thinking measured by BSS, BHS, and BDI 10 weeks post-infusion

    More Details

    NCT Number: NCT02418702
    Other IDs: NMCSD.2014.0031
    Study URL: https://clinicaltrials.gov/study/NCT02418702
    Last updated: Sep 29, 2023