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A Study to Decrease Suicidal Thinking Using Ketamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02418702
Recruitment Status : Withdrawn (PI no longer at facility.)
First Posted : April 16, 2015
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Tracking Information
First Submitted Date  ICMJE April 7, 2015
First Posted Date  ICMJE April 16, 2015
Last Update Posted Date September 3, 2019
Estimated Study Start Date  ICMJE August 2016
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • 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
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2015)
  • 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
  • Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 2 weeks post-infusion ]
  • Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 10 weeks post-infusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Decrease Suicidal Thinking Using Ketamine
Official Title  ICMJE A Randomized Controlled Trial 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Suicide
Intervention  ICMJE
  • Drug: 0.2 mg/kg ketamine
    20 patients will randomly be assigned 0.2 mg/kg of Ketamine
    Other Name: Ketamine
  • Other: placebo
    20 patients will randomly be assigned a placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: 0.2 mg/kg ketamine
  • Placebo Comparator: placebo
    After being assessed, and giving informed consent, participants would receive a placebo. Symptoms will be monitored.
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: August 29, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2015)
40
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02418702
Other Study ID Numbers  ICMJE NMCSD.2014.0031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party United States Naval Medical Center, San Diego
Study Sponsor  ICMJE United States Naval Medical Center, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc A Capobianco United States Naval Medical Center, San Diego
PRS Account United States Naval Medical Center, San Diego
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP