What side effects are associated with this type of intervention?

Ketamine, an NMDA receptor antagonist used in treating suicidality, is known for its rapid antidepressant effects but can cause side effects such as dizziness, dissociation, increased blood pressure, nausea, and potential for psychosis. Psychosocial interventions like the Crisis Response Plan generally have minimal side effects but require patient engagement and can vary in effectiveness.

What prior FDA approvals exist?

The FDA has approved esketamine, a derivative of ketamine and an NMDA receptor antagonist, for the treatment of treatment-resistant depression and acute suicidal ideation or behavior. Esketamine is administered intranasally and has shown rapid effects in reducing depressive symptoms and suicidal thoughts. While traditional antidepressants like SSRIs and SNRIs are commonly used, they are not specifically approved for acute suicidality. Psychosocial interventions, such as cognitive-behavioral therapy (CBT) and crisis response plans, are also critical components in managing suicidality, although they do not have FDA approval as standalone treatments.

What other types of research exist?

Promising novel alternatives to Ketamine and Crisis Response Plan for suicide patients include: 1) Esketamine (a derivative of Ketamine) which has shown rapid antidepressant effects and is FDA-approved for treatment-resistant depression. 2) Psilocybin, which is being studied for its rapid and sustained antidepressant effects in clinical trials. 3) Digital Cognitive Behavioral Therapy (CBT) platforms, which provide accessible, evidence-based psychosocial support. 4) Lithium, which has been shown to reduce suicide risk in patients with mood disorders. These alternatives offer both pharmacological and psychosocial benefits and are supported by emerging research.

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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

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

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

Do I qualify?Apply below to find out

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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

467 Previous Clinical Trials

91,740 Total Patients Enrolled

4 Trials studying Suicide

504 Patients Enrolled for Suicide

National Center for Advancing Translational Sciences (NCATS)NIH

342 Previous Clinical Trials

410,444 Total Patients Enrolled

2 Trials studying Suicide

80 Patients Enrolled for Suicide

Alan Peterson, PhD, ABPPStudy DirectorUT Health San Antonio

2 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Ketamine Hydrochloride (NMDA Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05696691 — Phase 2 & 3

Suicide Research Study Groups: Treatment as Usual, Ketamine and Crisis Response Plan (CRP)

Suicide Clinical Trial 2023: Ketamine Hydrochloride Highlights & Side Effects. Trial Name: NCT05696691 — Phase 2 & 3

Ketamine Hydrochloride (NMDA Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696691 — Phase 2 & 3

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