Ketamine hydrochloride injection for Suicidal Thoughts

Comprehensive Psychiatric Emergency Department of Columbia University Medical Center, New York, NY
Suicidal Thoughts+2 More ConditionsKetamine hydrochloride injection - Drug
18 - 65
All Sexes

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.

Eligible Conditions
  • Suicidal Thoughts
  • Major Depressive Disorder
  • Depression, Bipolar Disorder

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 24 hours post-treatment

24 hours post-treatment
Scale for Suicidal Ideation (SSI)
Systematic Assessment for Treatment Emergent Events (SAFTEE)

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Active Control

Experimental Treatment

90 Total Participants · 2 Treatment Groups

Primary Treatment: Ketamine hydrochloride injection · No Placebo Group · Phase 4

Experimental Group · 1 Intervention: Ketamine hydrochloride injection · Intervention Types: Drug
ActiveComparator Group · 1 Intervention: Midazolam injection · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours post-treatment

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
463 Previous Clinical Trials
150,377 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,619 Previous Clinical Trials
1,983,167 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.

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with major depressive disorder, either as unipolar or bipolar.

Who else is applying?

What state do they live in?
New Mexico50.0%
Rhode Island25.0%
New York25.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Comprehensive Psychiatric Emergency Department of Columbia University Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?

Frequently Asked Questions

Are there any remaining openings to join this medical experiment?

"Indeed, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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

"Confirmed. The clinical trial listing on 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.