Ketamine for Suicidal Thoughts

Recruiting at 1 trial location

Overseen By Lucas Lemar

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Lindsay Maguire, MD

Disqualifiers: Psychosis, Mania, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 2 hours

50 Participants Needed

Trial Summary

What is the purpose of this trial?

There is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the Emergency Department (ED). Investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ED with suicidal ideation.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if your medication would interfere with ketamine treatment, the treating physician might advise against participating.

How is the drug ketamine unique in treating suicidal thoughts?

Ketamine is unique in treating suicidal thoughts because it works quickly, often within hours, by affecting the brain's glutamate system, which is different from traditional antidepressants that can take weeks to show effects. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for individuals in the emergency department with suicidal thoughts or behaviors, who are fully conscious (GCS 15). It's not suitable for those with a history of psychosis, clinical intoxication, extreme blood pressure issues, pregnancy, inability to consent, known adverse reactions to ketamine, involuntary psychiatric hold or those needing medical admission.

Inclusion Criteria

You are exhibiting signs of active or passive suicidal behavior.

GCS 15

Exclusion Criteria

Allergy, intolerance, or previous adverse reaction to ketamine

Involuntary status

My blood pressure is not higher than 180/100.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive a single IV dose of ketamine and are observed in the ED for 2 hours

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for changes in depressive and suicidal symptoms with surveys at 0, 2, 24, and 72 hours

72 hours

4 visits (virtual)

Hospitalization

Participants are transferred to a psychiatric hospital for further care and monitoring

up to 2 weeks

Treatment Details

Interventions

• Ketamine

Trial Overview The study tests low-dose intravenous ketamine as an immediate treatment for patients presenting with suicidal ideation in the emergency department. The goal is to see if it's feasible and safe to use this drug that has shown promise in treating resistant depression.

Participant Groups

Group I: Ketamine Experimental Treatment 1 Intervention

All patients will receive the experimental drug.

Ketamine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in European Union as Ketalar for:

• Anesthesia
• Treatment-resistant depression

Approved in United States as Spravato for:

• Treatment-resistant depression

Approved in European Union as Spravato for:

• Treatment-resistant depression

Approved in Canada as Spravato for:

• Treatment-resistant depression

Who Is Running the Clinical Trial?

Lindsay Maguire, MD

Lead Sponsor

Trials

1

Recruited

50+

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Findings from Research

In a study of 25 patients with acute vertebral compression fractures (AVCF) treated with either bipedicular (BPKP) or unipedicular (UPKP) percutaneous kyphoplasty, both methods showed similar overall clinical efficacy after 12 months, with no complications reported.

However, patients in the BPKP group experienced significantly lower pain scores (VAS) at the 12-month follow-up and had more symmetrical and uniform distribution of bone cement compared to the UPKP group, suggesting BPKP may be the preferred approach for better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bipedicular percutaneous kyphoplasty versus unipedicular percutaneous kyphoplasty in the treatment of asymmetric osteoporotic vertebral compression fractures: a case control study. Liu, L., Song, F., Shang, J., et al.[2023]

A meta-analysis of 5 studies, including 3 randomized controlled trials, found that combining zoledronic acid with percutaneous kyphoplasty (PKP) significantly improves bone mineral density (BMD) and quality of life in patients with osteoporotic vertebral compression fractures (OVCFs).

Patients receiving the combination treatment experienced less severe low back pain and had fewer additional vertebral fractures compared to those who underwent PKP alone, indicating enhanced efficacy and safety of the combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zoledronic Acid in Osteoporotic Vertebral Compression Fractures Treated With Percutaneous Kyphoplasty: A Meta-Analysis. Tian, P., Liu, Y., Li, ZJ., et al.[2021]

In a study involving 233 patients with hyperopia, 12-month results showed that 91% achieved uncorrected visual acuity of 20/40 or better, indicating high efficacy of conductive keratoplasty (CK) for treating hyperopia.

The procedure demonstrated good safety and stability, with 58% of patients achieving a manifest refractive spherical equivalent within +/- 0.50 D, and minimal changes in residual refraction after 6 months, suggesting that CK provides a stable correction for hyperopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conductive keratoplasty for the correction of hyperopia. Asbell, PA., Maloney, RK., Davidorf, J., et al.[2022]

The Sky kyphoplasty system (SK) was found to be the most effective treatment for osteoporotic vertebral compression fractures (OVCFs), significantly reducing pain and improving vertebral height and kyphotic angle based on a network meta-analysis of 56 studies involving 6974 patients.

Radiofrequency kyphoplasty (RFK) demonstrated the best safety profile, effectively reducing the incidence of new fractures and adverse events compared to other interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison Between 7 Osteoporotic Vertebral Compression Fractures Treatments: Systematic Review and Network Meta-analysis. Chang, M., Zhang, C., Shi, J., et al.[2021]

In a study of five patients with severe fungal keratitis who did not respond to antifungal medications, penetrating keratoplasty (PKP) proved to be an effective treatment, with most corneal grafts remaining clear and no recurrence of fungal infection during follow-up periods of 4 to 15 months.

The results suggest that early surgical intervention with PKP can preserve vision and maintain eye integrity in advanced cases of fungal keratitis, although some patients experienced minor complications like graft rejection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of fungal keratitis by penetrating keratoplasty]. Imtirat, A., Levy, J., Lifshitz, T.[2010]

References

1. England pubmed.ncbi.nlm.nih.gov

Bipedicular percutaneous kyphoplasty versus unipedicular percutaneous kyphoplasty in the treatment of asymmetric osteoporotic vertebral compression fractures: a case control study. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Zoledronic Acid in Osteoporotic Vertebral Compression Fractures Treated With Percutaneous Kyphoplasty: A Meta-Analysis. [2021]

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

Conductive keratoplasty for the correction of hyperopia. [2022]

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

Comparison Between 7 Osteoporotic Vertebral Compression Fractures Treatments: Systematic Review and Network Meta-analysis. [2021]

5. Israel pubmed.ncbi.nlm.nih.gov

[Treatment of fungal keratitis by penetrating keratoplasty]. [2010]