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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

Tracking Information
First Submitted Date  ICMJE November 20, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date February 21, 2021
Actual Study Start Date  ICMJE January 2, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
Scale for Suicidal Ideation (SSI) [ Time Frame: 24 hours post-treatment ]
Beck Scale for Suicidal Ideation clinician-rated version
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2020)
Systematic Assessment for Treatment Emergent Events (SAFTEE) [ Time Frame: 24 hours post-treatment ]
Frequency of adverse events at 24 hours post-treatment
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IM Ketamine vs Midazolam for Suicidal ER Patients
Official Title  ICMJE IM Ketamine vs Midazolam for Suicidal ER Patients
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression, Unipolar
  • Depression, Bipolar
  • Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine hydrochloride injection
    single IM injection of ketamine hydrochloride 0.5 mg/kg
  • Drug: Midazolam injection
    single IM injection of midazolam 0.06 mg/kg
Study Arms  ICMJE
  • Experimental: Ketamine
    Ketamine hydrochloride 0.5 mg/kg IM single injection
    Intervention: Drug: Ketamine hydrochloride injection
  • Active Comparator: midazolam
    Midazolam 0.06 mg/kg IM single injection
    Intervention: Drug: Midazolam injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 20, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Meghan Enslow, BA 646-774-7564 meghan.enslow@nyspi.columbia.edu
Contact: Michael Grunebaum, MD 646-774-7573 michael.grunebaum@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640636
Other Study ID Numbers  ICMJE 8070
R01MH125155-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Michael Grunebaum, MD, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Michael Grunebaum, MD New York State Psychiatric Institute/Columbia University Irving Medical Center
PRS Account New York State Psychiatric Institute
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP