What side effects are associated with this type of intervention?

Intramuscular ketamine, used for rapid relief of suicidal thoughts, is associated with several side effects. Common adverse effects include disorientation, restlessness, dissociation, dizziness, delirium, psychosis, nausea, and vomiting. Additionally, ketamine can increase blood pressure, particularly at higher doses, and may prolong or enhance seizures due to its lower anticonvulsant properties compared to other anesthetics. Monitoring for these side effects is crucial during treatment.

What prior FDA approvals exist?

The FDA has approved esketamine, a derivative of ketamine, for the treatment of treatment-resistant depression and acute suicidal ideation or behavior. Esketamine is administered as a nasal spray and has shown rapid effects in reducing suicidal thoughts. This approval is significant as it provides a fast-acting option for patients in crisis, similar to the intramuscular ketamine being studied for rapid relief of suicidal thoughts in emergency settings.

What other types of research exist?

Promising novel alternatives to intramuscular ketamine for rapid relief of suicidal thoughts include psilocybin-assisted psychotherapy, which has shown sustained reductions in suicidal ideation, and MDMA-assisted psychotherapy, which is being explored for its potential benefits in treating PTSD and associated suicidal thoughts. Both treatments are currently in advanced stages of clinical research and have shown promising results in early trials.

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NMDA receptor antagonist

IM Ketamine vs Midazolam for Suicidal Thoughts

Phase 4

Waitlist Available

Led By Michael Grunebaum, MD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Medical contraindication to ketamine or midazolam

Inadequate understanding of English and/or lack of capacity for informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post-treatment

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests whether a shot of ketamine can quickly reduce suicidal thoughts in depressed adults who visit the emergency room. These patients are at high risk of suicide and need fast-acting treatment. Ketamine works by quickly changing brain chemicals to improve mood and reduce suicidal thoughts. It has been found to rapidly reduce depressive symptoms and suicidal thoughts, making it a potential fast-acting treatment for suicidality.

Who is the study for?

This trial is for adults in the emergency department with severe depression and suicidal thoughts who need hospitalization. They must have a certain score indicating suicidality, be experiencing a major depressive episode, and agree to stay in the hospital. It's not for pregnant women, those unable to consent or understand English, people with unstable health conditions like uncontrolled high blood pressure or heart issues, recent substance abuse, psychosis or mania, or intellectual disability.

What is being tested?

The study tests if an injection of ketamine can quickly reduce suicidal thoughts in patients compared to midazolam (a sedative). Participants are given one of these drugs while they're in the emergency room being evaluated for serious mental health concerns.

What are the potential side effects?

Ketamine may cause disorientation, elevated blood pressure, nausea or mood changes shortly after administration. Midazolam can lead to drowsiness, reduced breathing rate and coordination difficulties. Both drugs carry risks that vary based on individual health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a major depressive episode.

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I was advised to get inpatient treatment for suicidal thoughts by a psychiatrist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take ketamine or midazolam due to health reasons.

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I understand English well and can make informed decisions about my health.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Scale for Suicidal Ideation (SSI)

Secondary study objectives

Systematic Assessment for Treatment Emergent Events (SAFTEE)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: KetamineExperimental Treatment1 Intervention

Ketamine hydrochloride 0.5 mg/kg IM single injection

Group II: midazolamActive Control1 Intervention

Midazolam 0.06 mg/kg IM single injection

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Intramuscular ketamine is being studied for its rapid relief of suicidal thoughts due to its unique mechanism of action. Ketamine works primarily as an NMDA receptor antagonist, which leads to an increase in glutamate levels and subsequent activation of AMPA receptors. This cascade results in enhanced synaptic plasticity and connectivity, which can rapidly improve mood and reduce suicidal ideation. This rapid action is crucial for suicidal patients who require immediate intervention to prevent self-harm. Other treatments, such as SSRIs and SNRIs, work by increasing serotonin and norepinephrine levels but typically take weeks to show effects, making them less suitable for acute suicidal crises.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

478 Previous Clinical Trials

153,883 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,892 Previous Clinical Trials

2,722,637 Total Patients Enrolled

1 Trials studying Suicidal Thoughts

240 Patients Enrolled for Suicidal Thoughts

Michael Grunebaum, MD4.36 ReviewsPrincipal Investigator - New York State Psychiatric Institute/Columbia University Irving Medical Center

New York State Psychiatric Institute

1 Previous Clinical Trials

8 Total Patients Enrolled

5Patient Review

I've been blown away by how well Dr. Grunebaum has been able to treat me remotely during the pandemic. I would have thought that telehealth would be a poorer substitute for in-person visits, but I've been pleasantly surprised.