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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of low-dose ketamine, a drug often used for treatment-resistant depression, to assist people with suicidal thoughts in the emergency room. It marks the first phase of research to determine if ketamine can quickly reduce these thoughts when other options are unavailable. The trial seeks participants admitted for psychiatric care due to acute suicidal thoughts and receiving care at the University of Kansas Medical Center. As a Phase 1 trial, this research aims to understand how ketamine works in people, offering participants a chance to contribute to groundbreaking insights.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

A previous study showed that ketamine quickly alleviated depression and suicidal thoughts, which is promising for emergency situations. Research has also examined the safety of administering ketamine through an IV to patients with suicidal thoughts. These studies have generally found that patients tolerate it well.

However, some side effects can occur. People have reported dizziness or a faster heartbeat. Occasionally, they might feel confused or disoriented. These effects are usually temporary and subside after treatment ends.

The FDA has already approved ketamine for use as an anesthetic, indicating its basic safety is well established. This approval provides additional confidence in its safety when used for other conditions, such as treating suicidal thoughts. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for suicidal thoughts, which typically include antidepressants and psychotherapy, ketamine offers a unique and fast-acting approach. Most treatments take weeks to show their effects, but ketamine can potentially alleviate symptoms within hours or days. It works differently by targeting the brain's glutamate system, rather than the serotonin or norepinephrine pathways that traditional antidepressants focus on. Researchers are excited about ketamine because it provides an alternative for individuals who need rapid relief from suicidal ideation.

What evidence suggests that ketamine might be an effective treatment for suicidal thoughts?

Research has shown that ketamine, which participants in this trial will receive, can quickly reduce suicidal thoughts. Studies have found that just one dose of ketamine provides fast relief from severe suicidal feelings. For instance, one study discovered that ketamine worked better than midazolam in quickly lowering suicidal thoughts. Another study showed that ketamine significantly reduced suicidal thoughts within 40 minutes of administration. These results suggest that ketamine could be a promising treatment for people with urgent suicidal thoughts. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4614623/

The Effect of Intravenous Ketamine in Suicidal Ideation ... The results like previous studies show that ketamine is effective in reducing suicidal ideations. Yet in our study, the SSI score 40 minutes after the injection ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11823077/

Is ketamine efficacious for rapid treatment of acute suicidal ... This study aimed to evaluate the efficacy of a single infusion of ketamine in inducing rapid remission of severe suicidal ideation, compared to Midazolam.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01700829

NCT01700829 | Ketamine in the Treatment of Suicidal ... This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering ...

4. bmcresnotes.biomedcentral.com bmcresnotes.biomedcentral.com/articles/10.1186/s13104-024-07029-7

Is ketamine efficacious for rapid treatment of acute suicidal ... This study aimed to evaluate the efficacy of a single infusion of ketamine in inducing rapid remission of severe suicidal ideation, compared to Midazolam.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01944293

Ketamine for Suicidality in Bipolar Depression This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK470357/

Ketamine - StatPearls - NCBI Bookshelf - NIH Ketamine, through its NMDA antagonistic action, works rapidly in controlling symptoms of depression and acute suicidal ideation. Ketamine ...

7. drugs.com drugs.com/illicit/ketamine.html

Ketamine Abuse, Hazards & Overdose Ketamine, through blocking at the N-methyl-D-aspartate (NMDA) site, has rapid action in controlling symptoms of depression and acute suicidal ideation. At ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2018/016812s040lbl.pdf

ketamine - accessdata.fda.gov WHEN KETALAR IS USED ON AN OUTPATIENT BASIS, THE PATIENT SHOULD NOT BE RELEASED. UNTIL RECOVERY FROM ANESTHESIA IS COMPLETE AND THEN SHOULD BE ACCOMPANIED BY. A ...

9. go.drugbank.com go.drugbank.com/drugs/DB01221

Ketamine: Uses, Interactions, Mechanism of Action Ketamine is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal-laryngeal reflexes.

10. hhs.texas.gov hhs.texas.gov/sites/default/files/documents/doing-business-with-hhs/provider-portal/facilities-regulation/psychiatric/monograph/ketamine-ketalar-monograph.pdf

Ketamine The studies summarized below evaluate the effects of iv ketamine's effects in patients with suicidal ideation and escalating iv ketamine doses.