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ED Treatment of Suicidal Patients With Ketamine Infusion

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ClinicalTrials.gov Identifier: NCT03502551
Recruitment Status : Withdrawn (Trial never received funding.)
First Posted : April 18, 2018
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
This study aims to determine if a single intravenous (IV) dose of ketamine given in the emergency department (ED) can provide a long term reduction in suicidal ideation, lower time to ED discharge, and increase discharge to home or voluntary treatment facilities all while being safe.

Condition or disease Intervention/treatment Phase
Suicide Suicidal Ideation Drug: Ketamine Phase 2

Detailed Description:

Suicide has risen to the 2nd leading cause of death in Americans aged 10 to 34, and is the10th leading cause of death overall. Globally, the World Health Organization estimates one person dies of suicide every 40 seconds. Despite its lethality, no recognized acute treatments for suicidality exist. Recently, ketamine, an N-methyl-D-aspartate (NMDA) receptor agonist, has been shown to rapidly reduce suicidality in small studies in psychiatric settings. However, most patients with acute suicidal thoughts are treated initially in Emergency Departments (EDs). Delays in treatment have both short and long term impacts on recovery as patients spend longer time frames in an actively suicidal state.

Identifying a rapid and effective treatment for suicidal ideation that can be administered in the ED would have a profound impact on the emergent management of patients with suicidal thoughts. Ketamine is an FDA approved medication that is commonly used in EDs for multiple indications. EDs have the familiarity, facilities and personnel to safely administer IV ketamine.

Ketamine is regularly used in EDs in high doses for procedural sedation in adults and children. It is also used in high doses as a sedative for acutely agitated patients. In low-doses ketamine is frequently used for its analgesic properties and is considered safe.

Ketamine has also been safely used in the pre-hospital setting. In a recent joint policy statement of the American College of Emergency Physicians recommended the use of low-dose ketamine for pain in control with a safety profile comparable to other intravenous analgesia such as morphine.

Use of Ketamine to rapidly reduce suicidality may facilitate a safe and faster transition of acutely suicidal patients to outpatient treatment. Such treatment potentially shortens these patients' ED and hospital lengths of stay.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ED Treatment of Suicidal Patients With Ketamine Infusion
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment with Ketamine
In this arm an IV infusion of 0.5 mg/kg of ketamine will be administered over 40 minutes.
Drug: Ketamine
Ketamine infusion (0.5 mg/kg) over 40 minutes.
Other Name: Ketalar




Primary Outcome Measures :
  1. Suicidal ideation at 24 hours post-infusion [ Time Frame: 24 hours post-infusion ]
    Suicidal ideation as measured by the Montgomery-Asberg Depression Scale (MARDS) will be assessed at 24 hours post-infusion of ketamine. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.

  2. Incidence of Discharge to Outpatient vs. Inpatient Facilities [ Time Frame: Through ED stay, an average of 53 hours ]
    The investigators will collect information about what location patients enrolled in this study are discharged to (E.g. home, outpatient crisis residential facility, inpatient psychiatric hospital, admission to general hospital).

  3. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 1 week from enrollment. ]
    Patients will be monitored for adverse events during the course of this study.


Secondary Outcome Measures :
  1. Overall MARDS score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. The scale is a series of 10 questions each having a possible score of 0-6. Total scores are reported on a scale from 0-60, with lower numbers indicating less depression and higher numbers indicative of increasing depression.

  2. MARDS Suicidal Ideation (MARDS-SI) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The MARDS will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Item 10 on the MARDS serves to specifically measure suicidal ideation with a score of 4 or greater being considered to indicate marked suicidal ideations.

  3. Scale for Suicide Ideation-5 (SSI5) score [ Time Frame: 1 hour, 3 days, and 1 week post-infusion ]
    The Scale for Suicide Ideation (SSI) will be administered regularly throughout the study and will serve as a measure of suicidal ideation. Items 1-5 on the SSI serves to specifically measure suicidal ideation. Each of the five questions on the scale have three possible answers with scores ranging from 0 (no suicidal ideation) to 2 (increased suicidal ideation). To compute the SSI5, the scores from each of the five questions are added together to give an overall score from 0-10, where 0 is no suicidal ideation and 10 is increased suicidal ideation.

  4. ED length of stay [ Time Frame: Through ED stay, an average of 53 hours ]
    The investigators will measure the amount of time that patients in this study remain in the ED before being discharged or transferred.



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

Inclusion Criteria:

  • Age ≥ 18 years
  • Chief complaint of suicidal thoughts with a MADRS-SI score > 3
  • Major depressive episode with MADRS > 19 (moderate to severe)

Exclusion Criteria:

  • Pregnancy
  • Psychosis
  • Acute intoxication with alcohol or illicit drugs
  • Acute withdrawal from alcohol or illicit drugs
  • Adults otherwise unable to consent
  • Concurrent, active medical illness requiring medical hospitalization
  • Inability to follow-up including no permanent address or valid telephone number
  • Patients unable to attend outpatient follow-up (no medical insurance, refusal to follow-up, no established care provider)
  • Specific contraindication to the use of ketamine (concern for increased intracranial or intraocular pressure, known allergy to ketamine)
  • Greater than 12 hours from time of ED presentation
  • Prisoners

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): NCT03502551


Locations
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United States, California
University of California Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Aimee Moulin, MD University of California, Davis

Publications:

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03502551     History of Changes
Other Study ID Numbers: 1197884
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by University of California, Davis:
ketamine
suicide
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
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