Ketamine Injectable Solution for Suicidal Thoughts

BC Children's Hospital, Vancouver, Canada
Suicidal ThoughtsKetamine Injectable Solution - Drug
Eligibility
10 - 17
All Sexes

Study 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.

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

0 Primary · 7 Secondary · Reporting Duration: 24 hours, 7-, 14-, 21-, and 28 days

24 hours
Columbia Suicide Severity Rating Scale (C-SSRS)
Day 28
Montgomery-Åsberg Depression Rating Scale (MADRS)
Pragmatic questionnaire
28-days
Demographics
Drug reactions
Enrolment rate
90 minutes post infusion
Blinding assessment

Trial Safety

Awards & Highlights

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

3 Treatment Groups

Intravenous midazolam
1 of 3
Intravenous ketamine
1 of 3
Intravenous saline
1 of 3

Active Control

Experimental Treatment

Non-Treatment Group

96 Total Participants · 3 Treatment Groups

Primary Treatment: Ketamine Injectable Solution · Has Placebo Group · Phase 1 & 2

Intravenous ketamine
Drug
Experimental Group · 1 Intervention: Ketamine Injectable Solution · Intervention Types: Drug
Intravenous midazolam
Drug
ActiveComparator Group · 1 Intervention: Midazolam Injectable Solution · Intervention Types: Drug
Intravenous saline
Drug
PlaceboComparator Group · 1 Intervention: Normal Saline 0.9% Injectable Solution · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 hours, 7-, 14-, 21-, and 28 days

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,354 Previous Clinical Trials
1,564,765 Total Patients Enrolled
Quynh Doan, PhD MHSc MDPrincipal InvestigatorUniversity of British Columbia

Eligibility Criteria

Age 10 - 17 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The study will include children and teenagers who come to the emergency department with self-injury.
You are between the ages of 10 and 17.
You have answered "yes" to either question 3, 4, or 5 on the C-SSRS questionnaire.
You have had thoughts of harming yourself, either passively or actively, as indicated by your response of "yes" to questions 1 or 2 on the C-SSRS.
A child psychiatrist has approved and deemed it suitable for you to be admitted to the Child and Adolescent Psychiatry Emergency (CAPE) unit.
You have understood the information provided about the study and are able to give your consent to participate.
Your doctor has checked your vital signs and nervous system and found no abnormalities.

Who else is applying?

What state do they live in?
Tennessee100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

Are any geriatric patients partaking in this research endeavor?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - 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.