Ketamine + Crisis Response Plan for Suicidal Thoughts

Overseen by Robert 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. ^{1 2 3 4 5}

Is 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. ^{2 5 6 7 8}

How is ketamine different from other drugs for suicidal thoughts?

Ketamine is unique because it can rapidly reduce suicidal thoughts within hours of a single low-dose infusion, with effects lasting up to a week, making it a potential crisis intervention for those at high risk of suicide. ^{1 2 4 5 9}

Research Team

Robert De Lorenzo, MD, MSM

Principal Investigator

UT Health San Antonio

Romeo Fairley, MD, MPH

Principal Investigator

UT Health San Antonio

Alan Peterson, PhD, ABPP

Principal Investigator

UT Health San Antonio

Stacey Young-McCaughan, RN, PhD

Principal Investigator

UT Health San Antonio

Eligibility 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

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.

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

Treatment Details

Interventions

• Crisis Response Plan (Behavioral Intervention)
• Ketamine Hydrochloride (NMDA Receptor Antagonist)

Trial Overview 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.

Participant Groups

Group I: Ketamine and Crisis Response Plan (CRP) Experimental Treatment 2 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 Usual Active Control 1 Intervention

Individuals randomized to the no intervention arm will receive routine care from emergency providers and psychiatry staff.

Ketamine Hydrochloride is already approved in Canada for the following indications:

Approved in Canada as Ketamine Hydrochloride for:

• Anesthesia
• Pain management
• Depression

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Dr. Andrew Masica

The University of Texas Health Science Center at San Antonio

Chief Medical Officer

MD from Indiana University School of Medicine

Dr. Taylor Eighmy

The University of Texas Health Science Center at San Antonio

Acting President

PhD in Civil Engineering from the University of New Hampshire

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dominique C. Pichard

National Center for Advancing Translational Sciences (NCATS)

Chief Medical Officer since 2023

MD

Joni L. Rutter

National Center for Advancing Translational Sciences (NCATS)

Chief Executive Officer since 2022

PhD in Pharmacology

Findings from Research

A single dose of ketamine can significantly reduce suicidal thoughts within an hour of administration, with effects lasting up to a week, making it a promising option for patients with severe or treatment-resistant depression.

The antisuicidal effects of ketamine occur independently of its impact on overall depression severity, indicating a unique mechanism of action that warrants further investigation for crisis intervention in suicidal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine for Depression, 6: Effects on Suicidal Ideation and Possible Use as Crisis Intervention in Patients at Suicide Risk. Andrade, C.[2022]

Low-dose ketamine infusion has shown rapid effects in reducing suicidal thoughts, making it a potentially valuable treatment in general hospital settings for patients at risk of suicide.

The treatment was reported to be efficient and well-tolerated in a patient who had recently attempted suicide, suggesting a favorable benefit-risk ratio for its use in acute care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Use for Suicidal Ideation in the General Hospital: Case Report and Short Review. Vulser, H., Vulser, C., Rieutord, M., et al.[2022]

A single intravenous infusion of ketamine (0.5 mg/kg) significantly reduces suicidal ideation within 4 hours and this effect can last up to 72 hours after treatment, based on a systematic review of 15 trials involving 572 participants.

While ketamine shows promise for short-term relief of suicidal thoughts, there is limited data on its long-term effects and actual suicidal behaviors, indicating a need for further research to sustain its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine for suicidal ideation in adults with psychiatric disorders: A systematic review and meta-analysis of treatment trials. Witt, K., Potts, J., Hubers, A., et al.[2020]

In a study of 14 outpatients with treatment-resistant depression and stable suicidal thoughts, ketamine infusions significantly reduced suicidal ideation, with 50% of participants showing remission during the treatment phase.

The effects of ketamine were rapid and robust, with some patients maintaining reduced suicidal thoughts for up to 3 months after treatment, indicating its potential as a critical intervention for those at risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. Ionescu, DF., Swee, MB., Pavone, KJ., et al.[2022]

In a study involving 16 recent suicide attempters, a single intravenous dose of ketamine (0.5 mg/kg) led to rapid and significant reductions in suicidal thoughts within 24 hours, with effects lasting up to 6 months post-infusion.

The results indicate that ketamine is a safe and effective treatment for reducing suicidality in high-risk patients, suggesting it could be integrated into existing healthcare settings for those in acute psychiatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. Shivanekar, S., Gopalan, P., Pizon, A., et al.[2023]

Subcutaneous (SC) administration of racemic ketamine and esketamine has shown rapid and robust antidepressant effects in both unipolar and bipolar patients, with response and remission rates ranging from 50% to 100% after single or multiple doses.

The studies indicated that SC ketamine is generally well-tolerated, with only transitory side effects, making it a promising and cost-effective treatment option for depression, especially in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Ketamine in Depression: A Systematic Review. Cavenaghi, VB., da Costa, LP., Lacerda, ALT., et al.[2021]

In a systematic review of 93 studies involving 3756 participants receiving sub-anesthetic doses of ketamine for psychiatric disorders, only four serious adverse medical events (MSAEs) were reported, resulting in an incidence of approximately 0.1%, indicating a very low risk of serious complications.

No serious cardiac events or deaths were observed, and most studies effectively screened out high-risk patients, suggesting that with proper medical screening, ketamine can be administered safely for psychiatric treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. Hovda, N., Gerrish, W., Frizzell, W., et al.[2023]

Ketamine has shown promising antidepressant and antisuicidal effects in adults, and recent studies indicate it may also be effective in adolescents, with the first placebo-controlled trial in 2021 demonstrating its superiority over midazolam.

While initial findings suggest that ketamine acts quickly to alleviate depression and reduce suicidal thoughts in adolescents, the studies conducted so far are small, highlighting the need for further research to confirm these results and guide clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine Use in Child and Adolescent Psychiatry: Emerging Data in Treatment-Resistant Depression, Insights from Adults, and Future Directions. Ryan, K., Hosanagar, A.[2023]

In a study of 80 adults with major depressive disorder and significant suicidal ideation, those receiving adjunctive ketamine showed a 4.96-point greater reduction in suicidal thoughts compared to those receiving midazolam within 24 hours.

Ketamine treatment resulted in a 55% response rate (≥50% reduction in suicidal ideation) compared to 30% for midazolam, indicating its potential as a rapid intervention for suicidal ideation in depression, with effects lasting up to 6 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial. Grunebaum, MF., Galfalvy, HC., Choo, TH., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Ketamine for Depression, 6: Effects on Suicidal Ideation and Possible Use as Crisis Intervention in Patients at Suicide Risk. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Ketamine Use for Suicidal Ideation in the General Hospital: Case Report and Short Review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Ketamine for suicidal ideation in adults with psychiatric disorders: A systematic review and meta-analysis of treatment trials. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Rapid and Sustained Reductions in Current Suicidal Ideation Following Repeated Doses of Intravenous Ketamine: Secondary Analysis of an Open-Label Study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study of Ketamine Infusion after Suicide Attempt: New Frontiers in Treating Acute Suicidality in a Real-World Medical Setting. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Subcutaneous Ketamine in Depression: A Systematic Review. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of the incidence of medical serious adverse events in sub-anesthetic ketamine treatment of psychiatric disorders. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Ketamine Use in Child and Adolescent Psychiatry: Emerging Data in Treatment-Resistant Depression, Insights from Adults, and Future Directions. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Ketamine for Rapid Reduction of Suicidal Thoughts in Major Depression: A Midazolam-Controlled Randomized Clinical Trial. [2022]