IM Ketamine vs Midazolam for Suicidal ER Patients

NCT04640636 | Suspended Phase 4 DMC FDA Drug

• 2 other identifiers: 8070-76595R01MH125155-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Unipolar; Depression, Bipolar; Suicidal Ideation

Keywords

depression; suicidality; clinical trial; ketamine; midazolam

Outcome Measures

Primary Outcomes (1)

• Scale for Suicidal Ideation (SSI)

  Beck Scale for Suicidal Ideation clinician-rated version

  24 hours post-treatment

Secondary Outcomes (1)

• Systematic Assessment for Treatment Emergent Events (SAFTEE)

  24 hours post-treatment

Study Arms (2)

Ketamine

EXPERIMENTAL

Ketamine hydrochloride 0.5 mg/kg IM single injection

Drug: Ketamine hydrochloride injection

midazolam

ACTIVE COMPARATOR

Midazolam 0.06 mg/kg IM single injection

Drug: Midazolam injection

Interventions

Ketamine hydrochloride injection DRUG

single IM injection of ketamine hydrochloride 0.5 mg/kg

Ketamine

Midazolam injection DRUG

single IM injection of midazolam 0.06 mg/kg

midazolam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Comprehensive Psychiatric Emergency Department of Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder; Bipolar Disorder; Suicidal Ideation; Depression

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael Grunebaum, MD

  New York State Psychiatric Institute/Columbia University Irving Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research psychiatrist

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 23, 2020
• Study Start: February 9, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

US (1)