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NMDA Receptor Antagonist
Ketamine + Crisis Response Plan for Suicidal Thoughts
Phase 2 & 3
Recruiting
Led By Robert De Lorenzo, MD, MSM
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial will assess if a combination of a one-time dose of ketamine and a brief psychosocial therapy can reduce suicidal ideation in acute suicidality cases in the ED.
Who is the study for?
This trial is for adults aged 18-70 who come to the Emergency Department with urgent suicidal thoughts and are cleared for psychiatric admission. They must be able to understand the study, consent voluntarily, and have a working phone for follow-ups. Excluded are those intoxicated, pregnant or breastfeeding, recent ketamine users, prisoners, under law enforcement custody unless released, or with severe physical/mental health conditions.Check my eligibility
What is being tested?
The trial tests if one dose of intramuscular ketamine (100mg) combined with a Crisis Response Plan can reduce suicidal thoughts in emergency department patients more effectively than current methods. It also explores whether weight-based dosing could improve outcomes.See study design
What are the potential side effects?
Ketamine may cause side effects like changes in blood pressure and heart rate, disorientation or confusion shortly after administration. Long-term side effects aren't expected as it's a single dose.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of study interventions
Secondary outcome measures
Change in Beck Scale for Suicidal Ideation (SSI) Score
Change in Depressive Symptoms Index-Suicidality Subscale (DSI-SS) Score
Change in Suicide Visual Analog Scale (S-VAS) Score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ketamine and Crisis Response Plan (CRP)Experimental Treatment2 Interventions
Individuals randomized to the experimental arm will receive 100mg intramuscular ketamine injection before completing the Crisis Response Plan. The average timeframe for the experimental arm is anticipated to be approximately 60 minutes of active treatment. Following ketamine administration, the subject will be monitored for 45 minutes with pulse oximetry and recurrent vital signs. The study team will record when the CRP is completed in relation to the ketamine injection.
Group II: Treatment as UsualActive Control1 Intervention
Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.
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?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,386 Total Patients Enrolled
4 Trials studying Suicide
504 Patients Enrolled for Suicide
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,725 Total Patients Enrolled
2 Trials studying Suicide
80 Patients Enrolled for Suicide
Stacey Young-McCaughan, RN, PhDStudy DirectorUT Health San Antonio
2 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 70 years old and currently have thoughts of harming myself.I am approved for admission to the psychiatric unit at University Hospital.I need sedation for a procedure due to my injury.I do not have severe heart, liver, or kidney disease.I am unable to understand and consent to the study on my own.
Research Study Groups:
This trial has the following groups:- Group 1: Ketamine and Crisis Response Plan (CRP)
- Group 2: Treatment as Usual
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can individuals under the age of thirty partake in this experiment?
"Adults aged 18-70 are eligible for recruitment in this study."
Answered by AI
What are the eligibility requirements to participate in this research trial?
"This trial seeks to enrol 24 willing participants that are enduring suicidal ideation and between 18-70 years of age."
Answered by AI
Is there still opportunity to enroll in this research endeavor?
"Yes, according to the information available on clinicaltrials.gov this trial is presently seeking participants. This research was initially posted on June 1st 2023 and was most recently modified on February 8th 2023; with 24 patients being sought from a single site."
Answered by AI
How many individuals are enrolled in this clinical research?
"That is correct. According to clinicaltrials.gov, the trial was first listed on January 6th 2023 and most recently updated on February 8th 2023; 24 patients are being sought at 1 medical center for participation in this active study."
Answered by AI
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