Suicidal IdeationPhase 1/2Keta4SINCT04955470
Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics
A Phase 1/2 study testing Ketamine Injectable Solution, Midazolam Injectable Solution and Normal Saline 0.9% Injectable Solution in people with Suicidal Ideation, run by University of British Columbia at 1 site in Canada.
Trial summary
Suicide is a leading cause of death for children and adolescents. Since warning signs of suicide and links to precipitating events differ between age groups, suicide can be difficult to predict. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Ketamine Injectable Solution, Midazolam Injectable Solution and Normal Saline 0.9% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2022to 1 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 10 to 17 years of age
- Respond "yes" to either question 1 (Passive Ideation) or 2 (Active Ideation) on the C-SSRS
- Respond "yes" to either questions 3 (Method), 4 (Intent), or 5 (Plan) on the C-SSRS
- Deemed acceptable and appropriate for admission to the on-site Child and Adolescent Psychiatry Emergency (CAPE) unit by a pediatric psychiatrist
- Successful completion of Capacity to Assent.
- Normal vital signs for age and a normal neurological exam (no focal deficits or abnormalities), as per attending clinician
Who cannot join
- History of benzodiazepine or ketamine use in the past 3 months (ample wash out period)
- Lifetime history of ketamine or benzodiazepine use disorder
- Previous diagnosis of schizophrenia or active psychosis as per the treating physician
- Lifetime history of schizoaffective disorder
- Current hypomania, mania, mixed state
- Clinically unstable, requires resuscitation or admission to a medical ward for stabilizing therapy (i.e., intensive care unit.)
Show all 16Show fewer
- History of cerebrovascular accident, uncontrolled seizure disorder, increased intracranial pressure
- Uncontrolled hypertension, low or labile blood pressure, severe cardiac decompensation
- Moderate to severe hepatic/renal impairment
- Intoxicated or delirious
- Suspected or confirmed pregnancy or women who are breastfeeding
- Known allergy or sensitivity to ketamine and/or midazolam or any component in the formulation.
- Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
- Inability to understand spoken and/or written English without the use of an interpreter
- Previous enrollment in this study
- No parent/guardian present.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics: a Pilot Randomized Controlled Trial
Suicide is a leading cause of death for children and adolescents. Since warning signs of suicide and links to precipitating events differ between age groups, suicide can be difficult to predict. As a result, children often seek care for suicidal ideation (SI) in the emergency department (ED) where a limited number of treatment options exist. Current psychotherapies and pharmacotherapies, such as antidepressants, provide benefit over weeks or months and thus limits their effective application in the ED. Consequently, when there is an imminent threat to the child's safety, the typical management solution is to admit the patient to a safe environment and hopefully de-escalate over time. To address a more rapid-onset treatment option for SI, a number of studies in adults have suggested that a single, sub-anesthetic dose of intravenous ketamine can rapidly reduce depression and SI severity. These results are promising, but large-scale trials are needed to determine if ketamine is a safe and effective treatment for acute suicidality in the pediatric population. This approach has the benefit of working rapidly, avoiding involuntary hospitalizations, and protecting patients from self-harm until they can be connected to longer term mental health resources. This study will compare the use of intravenous ketamine to both active and placebo controls in children 10 to 17 years of age presenting to the pediatric ED for SI. The primary objective of this pilot trial is to explore the adequacy and range of three instruments measuring suicidality and to determine the sample size required for a large definitive randomized control trial. This larger trial will be used to estimate the effectiveness of intravenous ketamine for reducing SI in children in the pediatric ED. The secondary objectives are to assess study feasibility and optimize study procedures. Given very few side effects reported in adult studies and the relatively benign nature of those reported, the investigators do not expect any major safety concerns in the study.
- Conditions
- Suicidal Ideation
- Being tested
- Ketamine Injectable Solution, Midazolam Injectable Solution, Normal Saline 0.9% Injectable Solution
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Injectable SolutionDrug
A 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg.
Midazolam Injectable SolutionDrug
A 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg.
Normal Saline 0.9% Injectable SolutionDrug
A 0.9% normal saline solution will be infused over a 40 minute period.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous ketamine | Experimental | Infusion of 0.5 mg/kg of ketamine, at maximum dose of 40 mg, over 40 minutes. Receives: Drug: Ketamine Injectable Solution |
| Intravenous midazolam | Active comparator | Infusion of 0.03 mg/kg of midazolam, at maximum dose of 2 mg, over 40 minutes. Receives: Drug: Midazolam Injectable Solution |
| Intravenous saline | Placebo comparator | Infusion of 0.9% saline over 40 minutes. Receives: Drug: Normal Saline 0.9% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale (C-SSRS)
The CSSR-S is 6-point scale that measures SI severity via clinical interviews, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). Adolescents who deny any SI receive a 0. The distribution of "yes" responses on questions 3, 4, or 5 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 90 minutes post infusion
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a 10-item, 6-point scale that screens for depressive symptoms in adults via clinical interviews. A self-reported version (MADRS-self assessment) which has been validated in adolescents will be used, but only the final item that is specific to SI (item 10) will be asked. The distribution of scores from 0 to 6 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 90 minutes post infusion
Pragmatic questionnaire
The pragmatic questionnaire is a brief, one sentence question designed to assess change in SI. Participants will be asked "How suicidal do you feel on a scale of 0 to 10?". The distribution of scores from 0 to 10 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 90 minutes post infusion
Secondary outcomes (7)
Columbia Suicide Severity Rating Scale (C-SSRS)
The CSSR-S is 6-point scale that measures SI severity via clinical interviews, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). Adolescents who deny any SI receive a 0. The distribution of "yes" responses on questions 3, 4, or 5 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 24 hours
Montgomery-Åsberg Depression Rating Scale (MADRS)
The MADRS is a 10-item, 6-point scale that screens for depressive symptoms in adults via clinical interviews. A self-reported version (MADRS-self assessment) which has been validated in adolescents will be used, but only the final item that is specific to SI (item 10) will be asked. The distribution of scores from 0 to 6 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 24 hours, 7-, 14-, 21-, and 28 days
Pragmatic questionnaire
The pragmatic questionnaire is a brief, one sentence question designed to assess change in SI. Participants will be asked "How suicidal do you feel on a scale of 0 to 10?". The distribution of scores from 0 to 10 will be assessed from baseline. Higher scores indicate greater SI severity.
Measured: 24 hours, 7-, 14-, 21-, and 28 days
Blinding assessment
The proportion of participants and research personnel that correctly identify treatment arm allocation.
Measured: 90 minutes post infusion
Enrolment rate
Proportion of eligible patients that consent to participate, and proportion of participants that are lost to follow-up at 7-, 14-, 21-, and 28-days.
Measured: 28-days
Demographics
Demographics of eligible patients who decline to participate in the study.
Measured: 28-days
Drug reactions
Incidence and frequency of side effects and adverse events.
Measured: 28-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Jun 2022
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Why it stopped: There were challenges with recruitment in the ED due to ED staffing shortages and we were unable to meet the expected recruitment rate. The decision to stop study recruitment was solely due to operational and logistical limitations.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quynh Doan, University of British Columbia
- Investigators
- Quynh Doan, PhD MHSc MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955470
- Sponsor's protocol ID
- H21-01433
- Acronym
- Keta4SI
- Status last verified
- Dec 2024
- First submitted
- 21 Jun 2021
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Onikashvili Y, Burt H, Meckler G, Bone JN, Hind T, Sih K, Sassi R, Stillwell K, Black T, Doan Q. A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department. CJEM. 2026 Jun 3. doi: 10.1007/s43678-026-01190-7. Online ahead of print.
PubMed 42234079
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04955470
- Acronym / sponsor ID
- Keta4SI / H21-01433
- Conditions
- Suicidal Ideation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were challenges with recruitment in the ED due to ED staffing shortages and we were unable to meet the expected recruitment rate. The decision to stop study recruitment was solely due to operational and logistical limitations.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 8 Jul 2021 (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.
Suicide is a leading cause of death for children and adolescents. Since warning signs of suicide and links to precipitating events differ between age groups, suicide can be difficult to predict. As a result, children often seek care for suicidal ideation (SI) in the emergency department (ED) where a limited number of treatment options exist. Current psychotherapies and pharmacotherapies, such as antidepressants, provide benefit over weeks or months and thus limits their effective application in the ED. Consequently, when there is an imminent threat to the child's safety, the typical management solution is to admit the patient to a safe environment and hopefully de-escalate over time. To address a more rapid-onset treatment option for SI, a number of studies in adults have suggested that a single, sub-anesthetic dose of intravenous ketamine can rapidly reduce depression and SI severity. These results are promising, but large-scale trials are needed to determine if ketamine is a safe and effective treatment for acute suicidality in the pediatric population. This approach has the benefit of working rapidly, avoiding involuntary hospitalizations, and protecting patients from self-harm until they can be connected to longer term mental health resources. This study will compare the use of intravenous ketamine to both active and placebo controls in children 10 to 17 years of age presenting to the pediatric ED for SI. The primary objective of this pilot trial is to explore the adequacy and range of three instruments measuring suicidality and to determine the sample size required for a large definitive randomized control trial. This larger trial will be used to estimate the effectiveness of intravenous ketamine for reducing SI in children in the pediatric ED. The secondary objectives are to assess study feasibility and optimize study procedures. Given very few side effects reported in adult studies and the relatively benign nature of those reported, the investigators do not expect any major safety concerns in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous ketamine | Experimental | Drug: Ketamine Injectable SolutionInfusion of 0.5 mg/kg of ketamine, at maximum dose of 40 mg, over 40 minutes. |
| Intravenous midazolam | Active comparator | Drug: Midazolam Injectable SolutionInfusion of 0.03 mg/kg of midazolam, at maximum dose of 2 mg, over 40 minutes. |
| Intravenous saline | Placebo comparator | Drug: Normal Saline 0.9% Injectable SolutionInfusion of 0.9% saline over 40 minutes. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 10 to 17 years of age
- Respond "yes" to either question 1 (Passive Ideation) or 2 (Active Ideation) on the C-SSRS
- Respond "yes" to either questions 3 (Method), 4 (Intent), or 5 (Plan) on the C-SSRS
- Deemed acceptable and appropriate for admission to the on-site Child and Adolescent Psychiatry Emergency (CAPE) unit by a pediatric psychiatrist
- Successful completion of Capacity to Assent.
Key exclusion criteria (16 listed)
- History of benzodiazepine or ketamine use in the past 3 months (ample wash out period)
- Lifetime history of ketamine or benzodiazepine use disorder
- Previous diagnosis of schizophrenia or active psychosis as per the treating physician
- Lifetime history of schizoaffective disorder
- Current hypomania, mania, mixed state
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 |
|---|---|---|
| Ketamine Injectable SolutionA 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg. | Drug | Intravenous ketamine |
| Midazolam Injectable SolutionA 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg. | Drug | Intravenous midazolam |
| Normal Saline 0.9% Injectable SolutionA 0.9% normal saline solution will be infused over a 40 minute period. | Drug | Intravenous saline |
Primary outcome
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 90 minutes post infusion
The CSSR-S is 6-point scale that measures SI severity via clinical interviews, ranging from 1 (wish to be dead) to 5 (suicidal intent with plan). Adolescents who deny any SI receive a 0. The distribution of "yes" responses on questions 3, 4, or 5 will be assessed from baseline. Higher scores indicate greater SI severity.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 90 minutes post infusion
The MADRS is a 10-item, 6-point scale that screens for depressive symptoms in adults via clinical interviews. A self-reported version (MADRS-self assessment) which has been validated in adolescents will be used, but only the final item that is specific to SI (item 10) will be asked. The distribution of scores from 0 to 6 will be assessed from baseline. Higher scores indicate greater SI severity.
Pragmatic questionnaire
Time frame: 90 minutes post infusion
The pragmatic questionnaire is a brief, one sentence question designed to assess change in SI. Participants will be asked "How suicidal do you feel on a scale of 0 to 10?". The distribution of scores from 0 to 10 will be assessed from baseline. Higher scores indicate greater SI severity.
7 secondary outcomes
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 24 hours
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 24 hours, 7-, 14-, 21-, and 28 days
Pragmatic questionnaire
Time frame: 24 hours, 7-, 14-, 21-, and 28 days
Blinding assessment
Time frame: 90 minutes post infusion
Enrolment rate
Time frame: 28-days
Demographics
Time frame: 28-days
Drug reactions
Time frame: 28-days
Results and safety
The study was stopped early (reason given: There were challenges with recruitment in the ED due to ED staffing shortages and we were unable to meet the expected recruitment rate. The decision to stop study recruitment was solely due to operational and logistical limitations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Derived from this study: PubMed 42234079Onikashvili Y, Burt H, Meckler G, Bone JN, Hind T, Sih K, Sassi R, Stillwell K, Black T, Doan Q. A pilot randomized trial of ketamine for suicidal ideation in a pediatric emergency department. CJEM. 2026 Jun 3. doi: 10.1007/s43678-026-01190-7. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Quynh Doan, PhD MHSc MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ketamine Injectable Solution, Midazolam Injectable Solution and Normal Saline 0.9% Injectable Solution in people with Suicidal Ideation, run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: There were challenges with recruitment in the ED due to ED staffing shortages and we were unable to meet the expected recruitment rate. The decision to stop study recruitment was solely due to operational and logistical limitations.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: 90 minutes post infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955470, which also lists 1 linked publication.
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 18 Dec 2024.