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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
No Placebo-Only Group
Summary
This trial tests a combination of ketamine and a short therapy session for suicidal patients in the emergency department. It aims to see if this approach quickly reduces suicidal thoughts. The study focuses on adults at high risk of suicide who need urgent help. Ketamine has been identified as a potential fast-acting treatment for reducing suicidal thoughts, with evidence suggesting rapid but short-term effects.
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of study interventions
Secondary study objectives
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~1890
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Ketamine, an NMDA receptor antagonist, works by blocking NMDA receptors in the brain, leading to a rapid increase in glutamate levels, which can quickly alleviate depressive symptoms and reduce suicidal ideation. The Crisis Response Plan is a psychosocial intervention that helps patients manage suicidal thoughts by creating a personalized plan that includes identifying warning signs, coping strategies, and sources of support.
These mechanisms are important for suicide patients as ketamine provides rapid relief from acute suicidal ideation, while the Crisis Response Plan offers long-term strategies to manage and prevent future crises.
Problem-Focused Psychodynamic Psychotherapies.
Problem-Focused Psychodynamic Psychotherapies.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,292 Total Patients Enrolled
National Center for Advancing Translational Sciences (NCATS)NIH
359 Previous Clinical Trials
411,234 Total Patients Enrolled
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: Treatment as Usual
- Group 2: Ketamine and Crisis Response Plan (CRP)
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.
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