Clinical trial NCT04640636: IM Ketamine vs Midazolam for Suicidal ER Patients
Official title: IM Ketamine vs Midazolam for Suicidal ER Patients
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Depression, Unipolar
Depression, Bipolar
Suicidal Ideation
Keywords: depression
suicidality
clinical trial
ketamine
midazolam
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-11-23
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

NOTE: The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023.

The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.

Non-HHS Studies: The IO in concurrence with the IRB paused human subjects research on June 12, 2023. Therefore, the NYSPI site is not enrolling at this time.

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.

Eligibility 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.

Primary outcomes:
measure: Scale for Suicidal Ideation (SSI)
timeFrame: 24 hours post-treatment
Secondary outcomes:
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE)
timeFrame: 24 hours post-treatment
Other outcomes:
Locations:
city: New York
country: United States
facility: Comprehensive Psychiatric Emergency Department of Columbia University Medical Center
state: New York
Study officials:
affiliation: New York State Psychiatric Institute/Columbia University Irving Medical Center
name: Michael Grunebaum, MD
role: PRINCIPAL_INVESTIGATOR
References: