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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 baseline

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment visit 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

Lightheadedness with low blood pressure

Pump Malfunction

PTSD

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Children's Hospital of Eastern OntarioLead Sponsor

126 Previous Clinical Trials

55,462 Total Patients Enrolled

1 Trials studying Suicidal Ideation

99 Patients Enrolled for Suicidal Ideation

Tyrus Crawford, BAStudy DirectorCHEO

Frequently Asked Questions

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

Are new participants still being accepted for enrollment in this research study?

"As per clinicaltrials.gov, this study is actively seeking volunteers. The trial was first listed on 1/15/2024 and last modified on 4/12/2024."

Answered by AI

Which individuals meet the criteria for eligibility to be enrolled in this research study?

"Individuals aged between 12 and 17 years experiencing suicidal ideation are eligible for this study. A total of 20 participants will be selected to partake in the trial."

Answered by AI

Is there an age restriction for participation in this trial, specifically regarding individuals older than 40 years?

"Participants in this research must be adolescents aged 12 to 17 years. There are a total of 81 trials available for individuals under 18 and 251 studies targeted towards those over the age of 65."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical study?

"Indeed, the details on clinicaltrials.gov reveal that this trial is actively seeking volunteers. The study was first listed on January 15th, 2024 and the most recent update was made on April 12th, 2024. They aim to recruit a total of 20 participants from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation

Maala Bhatt 2024. "Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06366334.