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Ketamine for Suicidal Ideation (KSI Trial)

N/A
Recruiting
Research Sponsored by Children's Hospital of Eastern Ontario
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-days post enrollment
Awards & highlights

KSI Trial Summary

This trial aims to study the use of ketamine to rapidly reduce suicidal thoughts in adolescents. Currently, there are no fast-acting treatments available for adolescents experiencing suicidal thoughts. Ketamine has been shown to

Who is the study for?
This trial is for Canadian adolescents who are experiencing suicidal thoughts and visit the emergency department. The study aims to see if ketamine, a medication used for sedation, can quickly reduce these thoughts in young people.Check my eligibility
What is being tested?
The trial is testing intravenous (IV) ketamine against a saline solution (placebo) to determine its effectiveness in rapidly reducing suicidal ideation among adolescents. It's designed to assess immediate relief and potential long-term benefits until psychiatric care is available.See study design
What are the potential side effects?
While not specified here, common side effects of IV ketamine may include dizziness, nausea, disorientation, elevated blood pressure or heart rate changes. These vary from person to person.

KSI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of eligible participants who complete the study protocol
Secondary outcome measures
Admission to Hospital
Assessment of blinding
Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5)
+10 more
Other outcome measures
Safety Outcome 1: Clinically significant tachycardia
Safety Outcome 2: Clinically significant hypertension
Safety Outcome 3: Vomiting
+2 more

Side effects data

From 2020 Phase 4 trial • 75 Patients • NCT03156504
1%
Lightheadedness with low blood pressure
1%
Pump Malfunction
1%
PTSD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ketamine

KSI Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: KetamineExperimental Treatment1 Intervention
Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes.
Group II: Normal SalinePlacebo Group1 Intervention
Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketamine Hydrochloride
2018
Completed Phase 4
~1000

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor
127 Previous Clinical Trials
55,122 Total Patients Enrolled
1 Trials studying Suicidal Ideation
99 Patients Enrolled for Suicidal Ideation
Tyrus Crawford, BAStudy DirectorCHEO
~13 spots leftby Jun 2025
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