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IM Ketamine vs Midazolam for Suicidal ER Patients

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ClinicalTrials.gov Identifier: NCT04640636
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Michael Grunebaum, MD, New York State Psychiatric Institute

Brief Summary:
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.

Condition or disease Intervention/treatment Phase
Depression, Unipolar Depression, Bipolar Suicidal Ideation Drug: Ketamine hydrochloride injection Drug: Midazolam injection Phase 4

Detailed Description:
Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. Clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, subanesthetic ketamine. We have received NIMH R01 funding to conduct a clinical trial of intramuscular (IM) ketamine in unipolar or bipolar depressed adults who present to the CUIMC psychiatric ED with suicidality severe enough to require inpatient hospitalization as judged by ED clinical staff. Clinical staff will ask potentially eligible patients if they would like to learn more about the study, and if so, a research assistant (RA) will describe the study to the patient and perform a basic eligibility screen. Key exclusions are unstable medical problems, substance abuse, psychosis, and further detail is provided in the Inclusion/Exclusion criteria. Participants (N=90) who enroll will undergo baseline clinical ratings, brief cognitive testing, and then be randomized, double-blind, in a 2:1 ratio to a single IM injection of ketamine (n=60) or midazolam comparator (n=30). Vital signs and clinical state will be monitored until injection effects subside (approximately 2 hrs). Blood samples will be drawn at 60 minutes and 90 minutes postinjection to assay ketamine level and a genetic sample will be stored. All participants will then be admitted to the 9GN inpatient unit for standard clinical treatment with periodic research follow-up ratings through 4 weeks post-discharge from hospital. Ongoing outpatient treatment will be arranged by the inpatient clinical team. Positive results from this trial would support a novel, easy-to-use, inexpensive, and scalable intervention for busy emergency clinicians to implement.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: IM Ketamine vs Midazolam for Suicidal ER Patients
Actual Study Start Date : January 2, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Ketamine
Ketamine hydrochloride 0.5 mg/kg IM single injection
Drug: Ketamine hydrochloride injection
single IM injection of ketamine hydrochloride 0.5 mg/kg

Active Comparator: midazolam
Midazolam 0.06 mg/kg IM single injection
Drug: Midazolam injection
single IM injection of midazolam 0.06 mg/kg




Primary Outcome Measures :
  1. Scale for Suicidal Ideation (SSI) [ Time Frame: 24 hours post-treatment ]
    Beck Scale for Suicidal Ideation clinician-rated version


Secondary Outcome Measures :
  1. Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: 24 hours post-treatment ]
    Frequency of adverse events at 24 hours post-treatment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • DSM5 unipolar or bipolar (I, II, or Unspecified) major depressive episode
  • Presenting to emergency department and assessed by psychiatrist staff as needing inpatient treatment due to suicidality
  • Participant agrees to voluntary inpatient psychiatric admission
  • Beck Scale for Suicidal Ideation score of 4 or higher

Exclusion Criteria:

  • Substance use disorder in past 2 weeks
  • Current psychosis or mania
  • Intellectual disability
  • Inadequate understanding of English and/or lack of capacity for informed consent
  • Pregnancy or lactation
  • Medical contraindication to ketamine or midazolam
  • Unstable medical or neurological illness such as uncontrolled hypertension, significant cardiac arrhythmia, unstable cerebrovascular disease. Chronic, stable medical conditions such as controlled hypertension or diabetes will not be excluded.

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): NCT04640636


Contacts
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Contact: Meghan Enslow, BA 646-774-7564 meghan.enslow@nyspi.columbia.edu
Contact: Michael Grunebaum, MD 646-774-7573 michael.grunebaum@nyspi.columbia.edu

Locations
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United States, New York
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Meghan Enslow, BA    646-774-7627    meghan.enslow@nyspi.columbia.edu   
Contact: Michael Grunebaum, MD    646-774-7573    michael.grunebaum@nyspi.columbia.edu   
Principal Investigator: Michael Grunebaum, MD         
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Michael Grunebaum, MD New York State Psychiatric Institute/Columbia University Irving Medical Center
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Responsible Party: Michael Grunebaum, MD, Research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04640636    
Other Study ID Numbers: 8070
R01MH125155-01 ( U.S. NIH Grant/Contract )
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All associated research findings published or provided to NIH, will be made readily available for research purposes to qualified individuals within the scientific community. All data will be made anonymous and available after written requests for data are submitted by such qualified individuals to the PI.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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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 Michael Grunebaum, MD, New York State Psychiatric Institute:
depression
suicidality
clinical trial
ketamine
midazolam
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Suicidal Ideation
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Suicide
Self-Injurious Behavior
Bipolar and Related Disorders
Midazolam
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
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs