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NMDA Receptor Antagonist

Ketamine for Adolescent Suicide Risk

Phase 2
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ages 13-17 years, inclusive
Failure to achieve remission with at least 2 antidepressant trials (e.g. SSRI, SNRI or TCA), meaning at least 6 weeks at therapeutic dosing, including at least 4 weeks of stable dosing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 11
Awards & highlights

Study Summary

This trial will compare ketamine to midazolam in adolescents with treatment resistant depression and a recent history of suicide attempt, emergency room evaluation for suicidal thinking, or transition to inpatient care for suicidality. The primary outcome measure will be change in suicidal ideation on the C-SSRS, recent ideation scale from baseline to 48 hours after first administration.

Who is the study for?
This trial is for adolescents aged 13-17 with treatment-resistant depression and a recent suicide event. They must have significant depressive symptoms, be medically healthy, not have used ketamine before, and agree to all study procedures. Exclusions include substance dependence (except tobacco), intellectual disability, cardiovascular issues, heavy body weight (>80 kg), or certain psychiatric conditions.Check my eligibility
What is being tested?
The trial tests if intravenous ketamine can reduce suicidal thoughts in adolescents more effectively than midazolam (the active placebo). Participants are assessed using the C-SSRS scale after receiving their first dose to see if there's an improvement in their suicidal ideation.See study design
What are the potential side effects?
Ketamine may cause side effects like disorientation, dizziness, nausea, increased blood pressure and heart rate changes. Midazolam can induce sleepiness, breathing issues, or mood changes. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 17 years old.
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I have tried at least 2 antidepressants for 6 weeks each without success.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Columbia-Suicide Severity Rating Scale (C-SSRS)
Secondary outcome measures
Change in Children's Depression Rating Scale
Montgomery Asberg Depression Rating Scale

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine InfusionExperimental Treatment1 Intervention
Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
Group II: Midazolam InfusionActive Control1 Intervention
Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,375 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,701 Total Patients Enrolled

Media Library

Ketamine Infusion (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04613453 — Phase 2
Adolescent Suicide Research Study Groups: Ketamine Infusion, Midazolam Infusion
Adolescent Suicide Clinical Trial 2023: Ketamine Infusion Highlights & Side Effects. Trial Name: NCT04613453 — Phase 2
Ketamine Infusion (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04613453 — Phase 2

Frequently Asked Questions

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

In what situations is Ketamine Infusion commonly prescribed?

"Ketamine Infusion is known to effectively address seizures, amnesia and various other therapeutically-relevant conditions."

Answered by AI

To whom is this clinical experiment accessible?

"This clinical trial seeks 66 minors between 13 and 17 years of age that have recently experienced a suicide event. The study's inclusion criteria mandate adequate antidepressant trials, positive results from the Children's Depression Rating Scale, Revised (CDRS-R) score ≥45 at screening as well as Columbia Suicide Severity Rating Scale ideation score of ≥ 1at screening. Moreover, parental permission and adolescent assent is mandatory for admittance into this research project with both parents needing to sign separate forms if applicable. Lastly, consenting participants must be willing to comply with all procedures throughout the duration of the study."

Answered by AI

Are there any opportunities for individuals to participate in this research project?

"Correct. According to the clinicaltrials.gov, this medical trial is currently seeking for suitable candidates and was initially posted on January 21st 2022 with the most recent update being August 22nd 2022. The study requires 66 participants from a single site."

Answered by AI

Are there any potential hazards associated with receiving a Ketamine Infusion?

"Based on the clinical data available, our team at Power assigned ketamine infusion a safety rating of 2 as this is only in Phase 2 trial. So far, there is evidence to suggest it's safe but none that can attest to its efficacy."

Answered by AI

Does this research encompass individuals of all ages, or is there a maximum age limit?

"The age range of participants eligible to enrol in this trial spans from 13 years to 17 years."

Answered by AI

How many people have been invited to partake in this research?

"Affirmative. Data found on clinicaltrials.gov indicates that this medical research project, which was labeled on January 21st 2022, is currently accepting participants. Approximately 66 individuals need to be recruited from a single site."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
How old are they?
< 18
What site did they apply to?
Yale New Haven Hospital
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Yale New Haven Hospital: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine
Michael Bloch 2022. "Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04613453.
~14 spots leftby Dec 2024
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