← Back to Search

NMDA Receptor Antagonist

Ketamine for Suicidal Thoughts in Children (Keta4SI Trial)

Phase 1 & 2
Recruiting
Led By Quynh Doan, PhD MHSc MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Successful completion of Capacity to Assent
10 to 17 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 7-, 14-, 21-, and 28 days
Awards & highlights

Keta4SI Trial Summary

This trial is testing whether ketamine can rapidly reduce depression and suicide severity in children, which could be a safer and more effective alternative to involuntary hospitalization.

Who is the study for?
This trial is for children aged 10-17 who are experiencing suicidal thoughts and have been deemed appropriate for psychiatric emergency care. They must be able to understand the study and agree to participate. Exclusions include those with certain mental health conditions, unstable medical states, drug allergies or sensitivities, recent substance use, pregnancy, or severe organ impairment.Check my eligibility
What is being tested?
The trial tests if a single dose of intravenous ketamine can quickly reduce suicidality in kids at the ER compared to active control (Midazolam) and placebo (Saline). It aims to find out how well different tools measure suicidality and determine the number of participants needed for a larger future trial.See study design
What are the potential side effects?
Ketamine may cause side effects like disorientation, dizziness, nausea, increased blood pressure or heart rate changes. Midazolam might induce sleepiness or breathing issues. Both drugs are generally considered safe with few serious side effects expected in this pediatric study.

Keta4SI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I understand and agree to participate in the study.
Select...
I am between 10 and 17 years old.

Keta4SI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours, 7-, 14-, 21-, and 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours, 7-, 14-, 21-, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Blinding assessment
Columbia Suicide Severity Rating Scale (C-SSRS)
Demographics
+4 more

Keta4SI Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Intravenous ketamineExperimental Treatment1 Intervention
Infusion of 0.5 mg/kg of ketamine, at maximum dose of 40 mg, over 40 minutes.
Group II: Intravenous midazolamActive Control1 Intervention
Infusion of 0.03 mg/kg of midazolam, at maximum dose of 2 mg, over 40 minutes.
Group III: Intravenous salinePlacebo Group1 Intervention
Infusion of 0.9% saline over 40 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Injectable Solution
2018
Completed Phase 1
~60

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,410 Previous Clinical Trials
1,766,513 Total Patients Enrolled
Quynh Doan, PhD MHSc MDPrincipal InvestigatorUniversity of British Columbia

Media Library

Ketamine Injectable Solution (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04955470 — Phase 1 & 2
Suicidal Thoughts Clinical Trial 2023: Ketamine Injectable Solution Highlights & Side Effects. Trial Name: NCT04955470 — Phase 1 & 2
Suicidal Thoughts Research Study Groups: Intravenous ketamine, Intravenous midazolam, Intravenous saline
Ketamine Injectable Solution (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04955470 — Phase 1 & 2

Frequently Asked Questions

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

Are any geriatric patients partaking in this research endeavor?

"This clinical study requires participants to be aged between 10 and 17 years old."

Answered by AI

How many individuals are capable of participating in this clinical trial?

"Indeed, clinicaltrials.gov reports that the trial is currently in need of participants. It was initially posted on June 1st 2022 and most recently updated on November 3rd 2022. The research requires 96 patients to be recruited from a single medical centre."

Answered by AI

Is there a possibility that I may be enrolled in this experiment?

"This clinical trial is recruiting 96 minors between 10 and 17 years old exhibiting suicidal ideation. To be eligible, they must have responded affirmatively to either Passive or Active Ideation on the C-SSRS, given consent for admission into an inpatient facility via Capacity to Assent protocol and show no neurological anomalies as evaluated by a paediatric psychiatrist. Additionally, their vitals will need to fall within age appropriate norms."

Answered by AI

Are there still enrollment opportunities for those interested in participating in this medical research?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical investigation was initially listed on June 1st 2022 and recently modified in November 3rd of the same year. Consequently, 96 individuals are needed for enrollment at a single site."

Answered by AI

In what instances is Ketamine Injectable Solution regularly prescribed?

"Ketamine Injectable Solution has been applied to manage seizures, epileptic episodes, amnesia and other therapeutic procedures."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~23 spots leftby Nov 2024