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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours post-treatment
Awards & highlights

Study Summary

This trial proposes the use of ketamine to relieve suicidal thoughts in depressed patients within hours of treatment. If successful, this would be a scalable intervention for busy emergency clinicians to implement.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Scale for Suicidal Ideation (SSI)
Secondary outcome measures
Systematic Assessment for Treatment Emergent Events (SAFTEE)

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

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,817 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,783 Previous Clinical Trials
2,689,037 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

Ketamine hydrochloride injection (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04640636 — Phase 4
Suicidal Thoughts Research Study Groups: Ketamine, midazolam
Suicidal Thoughts Clinical Trial 2023: Ketamine hydrochloride injection Highlights & Side Effects. Trial Name: NCT04640636 — Phase 4
Ketamine hydrochloride injection (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04640636 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any remaining openings to join this medical experiment?

"Indeed, clinicaltrials.gov corroborates that patient recruitment is underway for this trial which was first published on February 1st 2021 and last updated on March 8th 2022; with the objective of sourcing 90 participants from a single medical centre."

Answered by AI

Has the FDA granted authorization for Ketamine hydrochloride injection?

"Due to its approval status as a Phase 4 trial, Ketamine hydrochloride injection was assigned the maximum safety rating of 3."

Answered by AI

Do I qualify to partake in this medical experiment?

"This trial is seeking 90 individuals, aged 18 to 65 with suicidal ideation who have recently checked into an emergency department and been diagnosed by a psychiatrist. Additionally, they must present with a DSM5 major depressive episode (unipolar or bipolar), score 4+ on the Beck Scale for Suicidal Ideation assessment, and agree to voluntary psychiatric hospitalization."

Answered by AI

Does this trial include subjects who are of advanced age?

"The trial's eligibility criteria specify that the minimum age of participants is 18 and any patient over 65 won't be accepted."

Answered by AI

To what afflictions is Ketamine hydrochloride injection typically administered?

"Ketamine hydrochloride injection is traditionally used to treat seizures and epilepsy, yet can also be deployed to manage conditions such as amnesia, therapeutic procedure-related pain, and epileptic episodes."

Answered by AI

How many people have been admitted to partake in this experiment?

"Confirmed. The clinical trial listing on clinicialtrials.gov reveals that this medical research is currently recruiting participants, with an initial post date of January 2nd 2021 and last update occurring March 8th 2022. 90 individuals are required to be enrolled at a single centre for the study to proceed as planned."

Answered by AI

Who else is applying?

What state do they live in?
Rhode Island
New York
New Mexico
How old are they?
18 - 65
What site did they apply to?
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
IM Ketamine vs Midazolam for Suicidal ER Patients
Michael Grunebaum, MD 2021. "IM Ketamine vs Midazolam for Suicidal ER Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04640636.
All > Depression New York > Bipolar Disorder
~14 spots leftby Dec 2024
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