Ketamine + Crisis Response Plan for Suicidal Thoughts
Recruiting in Palo Alto (17 mi)
Overseen ByRobert De Lorenzo, MD, MSM
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Must not be taking: Ketamine
Disqualifiers: Psychosis, Intoxication, Pregnancy, Cardiovascular, others
No Placebo Group
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the drug Ketamine for reducing suicidal thoughts?
Research shows that ketamine can quickly reduce suicidal thoughts, with effects appearing within an hour and lasting up to a week. Studies indicate that even a single dose can have significant benefits, making it a promising option for crisis intervention in patients with suicidal ideation.
12345Is ketamine generally safe for use in humans?
Research suggests that ketamine, when used in low doses, is generally well-tolerated and can be a safe treatment option for reducing suicidal thoughts and depression. Some studies report that it has a favorable benefit-risk ratio, with only temporary side effects observed.
25678Eligibility Criteria
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.Inclusion 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.
Decision to admit the patient to the inpatient unit or psychiatric stabilization unit made prior to consent to prevent study procedures from complicating or influencing the disposition and treatment as usual for suicidal patients reporting to the ED
+2 more
Exclusion Criteria
Patient is a prisoner
Serious mental illness with active and significant signs of psychosis, mania, hallucinations, paranoia, agitation, and drug-induced or other toxidromic symptoms
I need sedation for a procedure due to my injury.
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Treatment
Participants receive a one-time dose of 100mg intramuscular ketamine and complete a Crisis Response Plan in the Emergency Department
60 minutes
1 visit (in-person)
Immediate Monitoring
Participants are monitored for 45 minutes post-ketamine administration with pulse oximetry and recurrent vital signs
45 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 2 hours, 3 days, and 1 month post-intervention
30 days
Telephone interviews and/or visits
Participant Groups
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.
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.
Ketamine Hydrochloride is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Ketalar for:
- Anesthesia
- Pain management
- Depression
- Suicidal ideation
🇪🇺 Approved in European Union as Ketamine Hydrochloride for:
- Anesthesia
- Pain management
- Treatment-resistant depression
🇨🇦 Approved in Canada as Ketamine Hydrochloride for:
- Anesthesia
- Pain management
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University HospitalSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
National Center for Advancing Translational Sciences (NCATS)Collaborator
References
Ketamine for Depression, 6: Effects on Suicidal Ideation and Possible Use as Crisis Intervention in Patients at Suicide Risk. [2022]A growing body of literature suggests that ketamine, administered in subanesthetic doses, has early-onset antidepressant action in patients with severe and even treatment-refractory depression. Many case reports, open-label studies, and randomized controlled trials (RCTs) suggest that ketamine may have dramatic antisuicidal effects, as well. This article examines the benefits of ketamine in patients with suicidal ideation with particular focus on the findings of recent RCTs and meta-analyses. Important findings are that a single dose of ketamine is associated with antisuicidal benefits that emerge within an hour of administration and persist for up to a week. The benefits are seen in patients with mild as well as clinically significant suicidal ideation. The benefits are observed in midazolam- as well as saline-controlled trials. Effect sizes are medium to large. The improvement in suicidal ideation is only partly explained by improvement in depression severity. It is concluded that there is consistent evidence that a single dose of ketamine has dramatic antisuicidal action that emerges almost immediately after dosing and persists for at least a week. The short- and intermediate-term safety and efficacy of ketamine as a crisis intervention treatment for suicidal patients merit study. Areas that need research are outlined.
Ketamine Use for Suicidal Ideation in the General Hospital: Case Report and Short Review. [2022]Low-dose infusion of ketamine may have rapid antisuicide properties. Such a treatment may therefore be useful in the general hospital to prevent suicide in an environment that cannot be made safe enough. We report on the use of ketamine as an efficient, well-tolerated treatment for persistent suicidal ideation in a patient hospitalized in a general hospital after a severe suicide attempt. Based on data in the literature, we suggest that the benefit-risk ratio for ketamine use in such a context is highly favorable.
Ketamine for suicidal ideation in adults with psychiatric disorders: A systematic review and meta-analysis of treatment trials. [2020]Ketamine may reduce suicidal ideation in treatment-resistant depression. But it is not known how quickly this occurs and how long it persists. We undertook a systematic review and meta-analysis to determine the short- and long-term effectiveness of ketamine for suicidality.
Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. [2022]Ketamine rapidly reduces thoughts of suicide in patients with treatment-resistant depression who are at low risk for suicide. However, the extent to which ketamine reduces thoughts of suicide in depressed patients with current suicidal ideation remains unknown.
A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. [2023]Ketamine, in research settings, rapidly reduces suicidal thoughts 2-24 h after a single infusion in patients with high suicidal ideation. In this study, the authors investigate ketamine's effects on suicidality in a real-world sample of recent suicide attempters on a tertiary-care Consultation-Liaison (CL) psychiatry service. Using an open-label design, 16 transdiagnostic CL patients were recruited, 18-65 years old, to receive a single dose of intravenous ketamine (0.5 mg/kg) in the acute medical setting. All were psychiatrically hospitalized post-infusion. Baseline suicidality and depression measures were compared to ratings taken at 24 h, 5 days, 12 days, and 1, 3 and 6 months post-infusion using paired t-tests. Across all measures, rapid, statistically significant decreases (p's < 0.001) were observed with large to very large effect sizes (Cohen's d's: 1.7-8.8) at acute timepoints (24 h; 5 days). These gains were uniformly maintained to 6 months post-infusion. Open-label ketamine appeared to rapidly and robustly reduced suicidal symptoms in an ultra-high-risk, heterogeneous, real-world sample. Ketamine infusion may therefore be a safe, feasible, viable method to rapidly reduce suicidality among medically hospitalized patients after a suicide attempt, with potentially enduring benefits. The current pilot findings suggest ketamine could be readily integrated into the settings where high-risk CL patients already receive healthcare, with the potential to become an important and novel tool in the treatment of suicidality.
Subcutaneous Ketamine in Depression: A Systematic Review. [2021]Background: Ketamine has been shown to produce a rapid and robust antidepressant effect. Though numerous routes of administration have been studied, subcutaneous (SC) has proven to be a convenient and cost-effective route making its use particularly relevant in developing countries. Here we provide a systematic review covering the use of SC racemic ketamine and esketamine in depression, including its efficacy, safety and tolerability. Methods: A systematic literature search was carried out, from inception through March, 2021, using PubMed/MEDLINE, EMBASE and Web of Science, with no limits of language. After identifying 159 potentially relevant articles, 12 articles were selected after applying our inclusion/exclusion criteria. These comprised two randomized clinical trials, five case-reports and five retrospective studies. Given the small number of studies found and their heterogeneous nature, a meta-analysis was not considered appropriate. Here we provide a synthesis of these data including participant characteristics, dose range, efficacy, safety/ tolerability. Risk of bias was accessed using the Cochrane risk of bias tool. Results: SC Ketamine was administered to unipolar and bipolar patients a single or multiple doses, weekly or twice-weekly, a dose-titration approach was made in major studies, dose ranged from 0.1 to 0.5 mg/Kg of racemic ketamine and 0.5-1 mg/Kg of esketamine. Across all studies, SC ketamine showed a rapid and robust antidepressant effect, with response/ remission rates from 50 to 100% following both single or multiple doses, with transitory side effects. Conclusion: SC racemic ketamine and esketamine in depression is a promising strategy showing beneficial efficacy and tolerability. Future studies exploring the SC route, its cost-effectiveness, and a direct comparison with IV and intranasal (IN) protocols are warranted. Systematic Review Registration: CRD42019137434.
A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. [2023]Limited published data exists that collates serious adverse outcomes involving ketamine as a psychiatric intervention. This systematic review assesses the reported incidence of medical serious adverse events (MSAEs), including but not limited to cardiovascular events, in patients receiving sub-anesthetic doses of ketamine for psychiatric disorders to guide practitioners during treatment planning, risk-benefit analyses, and the informed consent process.
Ketamine Use in Child and Adolescent Psychiatry: Emerging Data in Treatment-Resistant Depression, Insights from Adults, and Future Directions. [2023]The following review will explore ketamine's antidepressant and antisuicidal properties in adults, review of what is known about ketamine's safety in children, and summarize the limited information we have on ketamine's role in treating depression and suicidal ideation in adolescents with depression. Future directions for ketamine's role in child psychiatry based on animal and adult studies will also be explored.
Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial. [2022]Pharmacotherapy to rapidly relieve suicidal ideation in depression may reduce suicide risk. Rapid reduction in suicidal thoughts after ketamine treatment has mostly been studied in patients with low levels of suicidal ideation. The authors tested the acute effect of adjunctive subanesthetic intravenous ketamine on clinically significant suicidal ideation in patients with major depressive disorder.