IM Ketamine vs Midazolam for Suicidal ER Patients

Sponsor
New York State Psychiatric Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04640636
Collaborator
National Institute of Mental Health (NIMH) (NIH)
90
1
2
49.9
1.8

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 2, 2021
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Scale for Suicidal Ideation (SSI) [24 hours post-treatment]

    Beck Scale for Suicidal Ideation clinician-rated version

Secondary Outcome Measures

  1. Systematic Assessment for Treatment Emergent Events (SAFTEE) [24 hours post-treatment]

    Frequency of adverse events at 24 hours post-treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Comprehensive Psychiatric Emergency Department of Columbia University Medical Center New York New York United States 10032

Sponsors and Collaborators

  • New York State Psychiatric Institute
  • National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Michael Grunebaum, MD, New York State Psychiatric Institute/Columbia University Irving Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Michael Grunebaum, MD, Research psychiatrist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT04640636
Other Study ID Numbers:
  • 8070
  • R01MH125155-01
First Posted:
Nov 23, 2020
Last Update Posted:
Mar 10, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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, Research psychiatrist, New York State Psychiatric Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2022