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A Study to Decrease Suicidal Thinking Using Ketamine

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ClinicalTrials.gov Identifier: NCT02418702
Recruitment Status : Unknown
Verified August 2016 by United States Naval Medical Center, San Diego.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2015
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

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.

Condition or disease Intervention/treatment Phase
Depression Suicide Drug: 0.2 mg/kg ketamine Other: placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial to Decrease Suicidal Thinking Using Ketamine
Study Start Date : December 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

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.
Drug: 0.2 mg/kg ketamine
20 patients will randomly be assigned 0.2 mg/kg of Ketamine
Other Name: Ketamine

Placebo Comparator: placebo
After being assessed, and giving informed consent, participants would receive a placebo. Symptoms will be monitored.
Other: placebo
20 patients will randomly be assigned a placebo




Primary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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

  2. Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 2 weeks post-infusion ]
  3. Reduction in suicidal thinking measured by BSS, BHS, and BDI [ Time Frame: 10 weeks post-infusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02418702


Contacts
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Contact: Maria E Vargas mariaesperanza.s.vargas.ctr@mail.mil

Locations
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United States, California
Naval Medical Center San Diego Not yet recruiting
San Diego, California, United States, 92134
Contact: Maria E Vargas       mariaesperanza.s.vargas.ctr@mail.mil   
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
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Principal Investigator: Marc A Capobianco United States Naval Medical Center, San Diego

Publications:
Melville NA. Bolus dose of ketamine offers fast-acting alleviation of acute depression in ED setting. Medscape Medical News. September 29, 2010.
Messer MM, Haller IV. Maintenance ketamine treatment produces long-term recovery from depression. Primary Psychiatry. 2010; 17(4):48-50.

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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02418702     History of Changes
Other Study ID Numbers: NMCSD.2014.0031
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by United States Naval Medical Center, San Diego:
depression
suicide
ketamine
rapid intravenous bolus
sub-anesthetic dose
double-blind placebo control

Additional relevant MeSH terms:
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Ketamine
Depression
Suicide
Behavioral Symptoms
Self-Injurious Behavior
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action