SuicidePhase 1NCT06085937
Feasibility and Safety of Ketamine for Suicidal Patients in the Emergency Department
A Phase 1 study testing Ketamine in people with Suicide and Suicidal Ideation, run by Lindsay Maguire, MD at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicide, Suicidal Ideation, Depression
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2024to Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
- Require inpatient stabilization for SI or actions based on clinical observation and interview
- Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
- Have a Glasgow Coma Score (GCS) of 15
- Age 18-65
Who cannot join
- Current or past history of psychosis
- Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater
- History of ketamine use disorder
- History of liver transplant
- Pregnancy or breastfeeding
- Imprisonment or inability to consent
Show all 13Show fewer
- Positive urine drug screen or serum alcohol level
- Hypertension (SBP > 160 or DBP > 100 before administration of ketamine)
- Hypotension (SBP < 90)
- Presence of acute medical condition requiring admission to medical service
- Allergy, intolerance, or previous adverse reaction to ketamine
- Patient has 8+ lifetime ketamine exposures
- The treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lucas Lemar contact
United States2 sites, 2 recruiting
- Not yet recruiting
University of Kansas Strawberry Hill Campus
Kansas City, Kansas, 66101
Tyler Kjorvestad, MD, tkjorvestad@kumc.edu
- Recruiting
University of Kansas Medical Center Emergency Department
Kansas City, Kansas, 66160
Lindsay Maguire, MD, 8048144509, lmaguire@kumc.edu
About this study
Official title: Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department
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.
Read the detailed description
In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.
Specific aims are as follows:
- To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients.
- To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient.
- To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS.
- To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.
- Conditions
- Suicide, Suicidal Ideation, Depression
- Being tested
- Ketamine
- Medical subject headings
- Suicide, Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Patients will receive 0.2mg/kg of IV ketamine
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | All patients will receive the experimental drug. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes.
Measured: 2 hours
Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility]
A questionnaire will be given to providers and nursing staff to assess [1] perceived safety, [2] provider comfort, [3] perceived efficacy, and [4] perceived feasibility for ED use as rated on a Likert scale from 1-5, with 5 relaying best perceived outcomes.
Measured: 2 hours
Secondary outcomes (2)
Change in Suicidal Ideation
Change of SI in ED patients after ketamine administration, as measured by the Columbia Suicide Severity Rating Scale (ideation subscore range 1-5, with higher number indicating increasing suicidal ideation; intensity subscore rating 2-25, with higher number indicating greater severity of suicidal ideation) and Montgomery-Asberg Depression Rating Scale.
Measured: 72 hours
Hospital Length of Stay
Impact of administration of ketamine on overall psychiatric hospital length of stay.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start1 May 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lindsay Maguire, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lindsay Maguire, MD, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085937
- Sponsor's protocol ID
- STUDY00150830
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Single Dose Ketamine for Acutely Suicidal Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT06085937
- Acronym / sponsor ID
- STUDY00150830
- Conditions
- Suicide, Suicidal Ideation, Depression
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lindsay Maguire, MDUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. Select patients will be given 0.2mg/kg of ketamine IV and observed in the ED for two hours. Vital signs and symptoms will be monitored. Patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. Surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ED providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ED administration for this purpose.
Specific aims are as follows:
- To determine the safety of ketamine as a single IV dose in the ED for acutely suicidal patients.
- To determine the feasibility of ketamine administration in the ED for the acutely suicidal patient.
- To determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the MADRS and C-SSRS.
- To determine the impact on hospital length of stay calculated from ED arrival until discharge from admitting psychiatric hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineAll patients will receive the experimental drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acutely Suicidality ("yes" answer to any of items 4 or 5 on C-SSRS "Suicidal Ideation" category)
- Require inpatient stabilization for SI or actions based on clinical observation and interview
- Are accepted for psychiatric stabilization at the University of Kansas Medical Center's Strawberry Hill campus
- Have a Glasgow Coma Score (GCS) of 15
- Age 18-65
Key exclusion criteria (13 listed)
- Current or past history of psychosis
- Current or recent (past 4 weeks) symptoms of mania/hypomania as defined by Young Mania Rating Scale (YRMS) score of 12 or greater
- History of ketamine use disorder
- History of liver transplant
- Pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetaminePatients will receive 0.2mg/kg of IV ketamine | Drug | Ketamine |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 2 hours
Safety of use of ketamine for SI in the ED, as assessed by number and severity of reported serious adverse outcomes.
Provider and Nursing Attitudes toward use of Ketamine for Suicidal Patients in the ED [Feasibility]
Time frame: 2 hours
A questionnaire will be given to providers and nursing staff to assess [1] perceived safety, [2] provider comfort, [3] perceived efficacy, and [4] perceived feasibility for ED use as rated on a Likert scale from 1-5, with 5 relaying best perceived outcomes.
2 secondary outcomes
Change in Suicidal Ideation
Time frame: 72 hours
Hospital Length of Stay
Time frame: up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucas Lemar contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ketamine in people with Suicide and Suicidal Ideation, run by Lindsay Maguire, MD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lindsay Maguire, MD (913-588-3580, lmaguire@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.