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Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department

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: NCT04260607
Recruitment Status : Enrolling by invitation
First Posted : February 7, 2020
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Naval Medical Center Camp Lejeune

Brief Summary:
Current treatment for acutely suicidal patients are limited to hospitalization, psychotherapy, electro-convulsant therapy, or a combination of the aforementioned. However, this has added to the national boarding problem. Long term pharmacologic treatment for suicidal behaviors and mood stabilization has been studied in specific populations. In these populations, the decreases in suicidal ideation results from stabilization of the underlying psychiatric illness. Ketamine is most commonly used as an anesthetic with analgesic properties. It has been used off-label for pain management, procedural sedation, status epilepticus, and treatment resistant depression. It has been safely administered intravenously and well tolerated for chronic Post Traumatic Stress Disorder. It increases norepinephrine, dopamine, and serotonin through adrenergic neuron stimulation and prevention of catecholamine uptake. There is a strong corollary between stress and the development of depression and suicidal behaviors. It is proposed that the use of low dose intravenous ketamine may have benefit on the suicidal ideation of patients presenting to the Emergency Department.

Condition or disease Intervention/treatment Phase
Suicide Suicide Threat Depression Severe Drug: Ketamine Hydrochloride Drug: Normal saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Experimental versus Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Triple masked study (patient, healthcare provider, outcomes assessor) performed by pharmacy investigators not involved in study recruitment or assessment.
Primary Purpose: Treatment
Official Title: Initiating Ketamine in Acutely Suicidal Patients in the Emergency Department
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : January 14, 2021
Estimated Study Completion Date : January 14, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Experimental-Ketamine
single dose IV Ketamine (Ketalar) 0.5mg/kg in 100ml Normal Saline infused over 40 minutes
Drug: Ketamine Hydrochloride

Experimental Procedure

  1. Baseline evaluation of suicidal severity (BSSI) & degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
  2. The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
  3. Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
  4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
  5. Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect.
Other Name: Experimental Arm

Placebo Comparator: Placebo-Saline
100ml Normal Saline infused over 40 minutes
Drug: Normal saline

Experimental Procedure

  1. Baseline evaluation of suicidal severity (BSSI) & degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
  2. The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
  3. Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
  4. Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
  5. Post Normal Saline re-evaluation of outcome measure at one-week post infusion.
Other Name: Placebo Comparator




Primary Outcome Measures :
  1. Suicidal Severity-clinical efficacy [ Time Frame: 4 hour+/1 after infusion completion, performed for placebo and drug arms ]
    completion of BSSI to evaluate suicidal severity.

  2. Suicidal Severity-clinical efficacy [ Time Frame: 24-36 hours after infusion completion, performed for placebo and drug arms ]
    completion of BSSI to evaluate suicidal severity.

  3. Suicidal Severity-duration of efficacy [ Time Frame: 1week+/-1 day after infusion completion, performed for placebo and drug arms ]
    completion of BSSI to evaluate suicidal severity.

  4. Depression symptoms-clinical efficacy [ Time Frame: 4 hours +/-1 after infusion completion, performed for placebo and drug arms ]
    completion of MADRS-S to evaluate depression symptoms.

  5. Depression symptoms-clinical efficacy [ Time Frame: 24-46 hours after infusion completion, performed for placebo and drug arms ]
    completion of MADRS-S to evaluate depression symptoms.

  6. Depression symptoms-duration of efficacy [ Time Frame: 1 week +/-1 day after infusion completion, performed for placebo and drug arms ]
    completion of MADRS-S to evaluate depression symptoms.


Secondary Outcome Measures :
  1. Length of Stay [ Time Frame: performed on medical record review at 1 week ]
    inspection of admission and transfer or discharge date



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Subject Inclusion and Selection Criteria

  1. Patient demographics will consist of Active, Reserve, or retired military personnel or their dependents.

    Subjects must meet the following inclusion criteria:

  2. Adult (18 to 89 years old)
  3. Present with active SI
  4. Deemed to being admitted to inpatient psychiatric unit

Subject Exclusion Criteria:

  1. Age < 18 years old or > 89 years old
  2. Currently presenting with psychosis as determined by mental health consultant
  3. Have a history of Cognitive disorder that would impair understanding of consent
  4. Have a personal/family history of Schizophrenia
  5. Currently pregnant or nursing
  6. Serious and unstable medical condition/problems
  7. Inability to medically clear
  8. Non-English Speakers
  9. Civilian Humanitarians
  10. Have previously enrolled in this study

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): NCT04260607


Locations
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United States, North Carolina
Naval Medical Center Camp Lejeune
Camp Lejeune, North Carolina, United States, 28547
Sponsors and Collaborators
Naval Medical Center Camp Lejeune
Additional Information:
Publications of Results:

Other Publications:
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Responsible Party: Naval Medical Center Camp Lejeune
ClinicalTrials.gov Identifier: NCT04260607    
Other Study ID Numbers: NMCCL.2018.0011
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
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.: No
Keywords provided by Naval Medical Center Camp Lejeune:
ketamine
Additional relevant MeSH terms:
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Emergencies
Suicide
Behavioral Symptoms
Disease Attributes
Pathologic Processes
Self-Injurious Behavior
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