Your session is about to expire
← Back to Search
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 belowSelect...
I have been diagnosed with a major depressive episode.
Select...
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:Select...
I cannot take ketamine or midazolam due to health reasons.
Select...
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
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
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.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take ketamine or midazolam due to health reasons.I do not have any uncontrolled serious health conditions.You have used drugs or alcohol excessively in the past two weeks.A Beck Scale for Suicidal Ideation score of 4 or higher suggests that you may be suicidalI understand English well and can make informed decisions about my health.You are either pregnant or breastfeeding.You are currently experiencing severe mental illness with symptoms like hallucinations, delusions or extreme mood swings.You have an intellectual disability.I have been diagnosed with a major depressive episode.I was advised to get inpatient treatment for suicidal thoughts by a psychiatrist.I agree to go to a psychiatric hospital voluntarily.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine
- Group 2: midazolam
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Share this study with friends
Copy Link
Messenger