Suicidal IdeationKSINCT06366334
Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation
A study testing Ketamine Hydrochloride and Normal saline in people with Suicidal Ideation and Suicidal Ideas, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicidal Ideation, Suicidal Ideas
- What is being tested?
- Ketamine Hydrochloride and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2024to 28 Jun 2024
- Phase
- Interventional
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Responds "yes" to Ask Suicide Screening Question (ASQ) #5 at triage, which asks; "Are you having thoughts of killing yourself right now?"
- Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)
- Age 12 to 17 years, inclusive
- Medically clear (deemed fit for participation in the trial), as judged by the treating physician. Minimum criteria required to be deemed medically clear are: a) No evidence of serious physical injury requiring urgent intervention b) No evidence of acute ingestion requiring monitoring, blood tests, imaging or ECG or in the context of acute ingestion they have satisfied the requisite number of hours of post-ingestion monitoring with no further need for intervention.
Who cannot join
- Acute intoxication from any substance, including alcohol
- Previously enrolled in the current study or currently enrolled in another clinical trial
- History of intellectual disability or autism spectrum disorder by patient/parent report
- Active, or history of, psychosis or psychotic disorder
- History of non-psychiatric neurologic disorder (e.g., epilepsy)
- Any of the following contraindications to ketamine based on the drug monograph: a) Known allergy or hypersensitivity to ketamine by patient history b) History of cerebrovascular accident (stroke or aneurysm) c) History of elevated intracranial pressure or idiopathic intracranial hypertension d) Significant hypertension requiring daily medication e) Severe cardiac decompensation
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- On an involuntary psychiatric hold
- Requires physical or chemical restraint
- History of violence while in hospital
- Pregnant or breastfeeding
- Received opioids in the 2-hours prior to study screening
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Maala Bhatt, MD, MSc., 6137377600 ext. 4178, mbhatt@cheo.on.ca
Tyrus Crawford, 6137377600 ext. 4178, tcrawford@cheo.on.ca
About this study
Official title: A Double Blinded, Randomized, Placebo Controlled, Parallel Arm Pilot Trial of Intravenous Ketamine for Emergency Department Treatment of Suicidal Ideation in a Pediatric Population.
Approximately 20% of Canadian adolescents experience thoughts of suicide, or suicidal ideation (SI), and suicide is the second leading cause of death among Canadians aged 15-19 years. The emergency department at CHEO sees approximately four patients per day with SI. Even though this is a medical emergency, there are no fast-acting treatments available.
Ketamine is a medication that is commonly used to safely sedate children who require painful procedures in the emergency department. For nearly ten years, intravenous ketamine has also been shown to rapidly reduce SI in adults. However, ketamine as a treatment for SI has never been studied in adolescents. The primary study objective is to pilot a clinical trial that investigates intravenous ketamine to emergently treat SI in adolescents.
If intravenous ketamine can relieve symptoms of SI for youth, this would have tremendous effects on patients and would dramatically change how physicians treat adolescent mental health emergencies. If ketamine is effective for several weeks, as it is in adults, it will help temporize patients until they receive more long-term psychiatric care. At the system level, it has the potential to reduce emergency visits and lengthy admissions. The investigators feel that the results of this study will be generalizable to pediatric centres across Canada and beyond.
Read the detailed description
Suicidal ideation (SI) is a common and often severe cause of morbidity in adolescents. Patients frequently present to the emergency department (ED) with severe and distressing thoughts of self-harm or suicide, and yet, there is currently no acute therapeutic intervention to offer them. The standard of care for patients who do not require admission is to discharge them home with resources for websites, apps, or telephone help lines. These interactions fail to address the underlying suicidal thoughts and leave patients, families and providers feeling very dissatisfied. Medications are nearly never initiated in the ED and patients who are already taking anti-depressants experience a very slow therapeutic onset, and often with unfavourable side effects that make medication compliance difficult and sometimes impossible.
For nearly ten years, intravenous ketamine has been shown to be an efficacious acute therapy in adult patients with suicidal ideation. A single dose of intravenous (IV) ketamine can rapidly reduce the severity of suicidal ideation by moderate to large effect sizes (Cohen's d = 0.5-0.8) during an ED visit, in an adult population. However, it has never been studied in a pediatric population. The study primary objective is to determine the feasibility of conducting a trial that investigates the efficacy of IV ketamine to reduce suicidal ideation in adolescents in the pediatric emergency department.
If intravenous ketamine can rapidly alleviate the severity of SI for adolescents, this would have tremendous effects on patients and families and dramatically change how ED physicians treat pediatric mental health emergencies. It would increase patient safety, reduce patient distress, morbidity, possibly mortality and alleviate family stress. If the therapeutic effect of ketamine is maintained for several days, as it is in adults, it will help temporize patient symptoms while they are connected with more long-term psychiatric care. At the system level, it may reduce rates of ED visits and, often lengthy, admissions to hospital. The investigators feel that the results of this study will be generalizable to pediatric centres across Ontario, Canada and beyond.
- Conditions
- Suicidal Ideation, Suicidal Ideas
- Being tested
- Ketamine Hydrochloride, Normal saline
- 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 HydrochlorideDrug
Also called Ketamine
See arm description
Normal salineDrug
See arm description
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes. Receives: Drug: Ketamine Hydrochloride |
| Normal Saline | Placebo comparator | Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of eligible participants who complete the study protocol
This is a feasibility measure; the investigators will report the number of patients who are screened for participation, are eligible, eligible and consent, complete the intervention, complete study follow-up
Measured: Baseline
Secondary outcomes (14)
Baseline distribution of responses to the first 5 questions of Beck Scale for Suicidal Ideation (SSI5)
Estimates of central tendency (mean) and variance (standard deviation) from participant responses to the SSI5 at baseline will be measured and reported. These parameters will aid with sample size estimates for the larger definitive trial.
The first 5 questions of Beck Scale for Suicidal Ideation (SSI5) is a five item questionnaire scored from 0 to 10, with higher scores indicating more severe suicidal ideation.
Measured: Baseline
Baseline distribution of responses to the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)
Estimates of central tendency (mean) and variance (standard deviation) from participant responses to the MADRS10 at baseline will be measured and reported. These parameters will aid with sample size estimates for the larger definitive trial.
The MADRS is a 10 item, 6-point, depression scale. Item 10 rates suicidal ideation from 0 (Enjoys life or takes it as it comes), to 6 (Explicit plans for suicide when there is an opportunity. Active preparations for suicide) with higher scores indicating more severe suicidal ideation.
Measured: Baseline
Baseline distribution of responses to the suicide item (#9) from the Beck Depression Index (BDI9).
Estimates of central tendency (mean) and variance (standard deviation) from participant responses to the BDI9 at baseline will be measured and reported. These parameters will aid with sample size estimates for the larger definitive trial.
The Beck Depression Inventory is a 21 item depression questionnaire. Item 9 rates suicidal ideation from 0 (I don't have thoughts of killing myself) to 3 (I would kill myself if I had the chance) with higher scores indicating more severe suicidal ideation.
Measured: Baseline
Baseline pragmatic assessment of the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5), the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10), and the suicide item (#9) from the Beck Depression Index (BDI9).
Pragmatic assessment of the tool validity by asking each participant, which of the three tools best captures how they are feeling at baseline.
Measured: Baseline
Assessment of blinding
Blinding adequacy will be measured by asking each participant which intervention they think they received at the end of the 40 minute study drug infusion.
Measured: Baseline
Treatment efficacy measured by the Beck Scale for Suicidal Ideation (SSI5)
Change in suicidal ideation severity from baseline at the end of the 40-minute medication infusion will be measured using SSI5.
The first 5 questions of Beck Scale for Suicidal Ideation (SSI5) is a five item questionnaire scored from 0 to 10, with higher scores indicating more severe suicidal ideation.
Measured: 40 minutes after the beginning of the infusion
Treatment efficacy measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)
Change in suicidal ideation severity from baseline at the end of the 40-minute medication infusion will be measured using MADRS10.
The MADRS is a 10 item, 6-point, depression scale. Item 10 rates suicidal ideation from 0 (Enjoys life or takes it as it comes), to 6 (Explicit plans for suicide when there is an opportunity. Active preparations for suicide) with higher scores indicating more severe suicidal ideation.
Measured: 40 minutes after the beginning of the infusion
Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9)
Change in suicidal ideation severity from baseline at the end of the 40-minute medication infusion will be measured using BDI9.
The Beck Depression Inventory is a 21 item depression questionnaire. Item 9 rates suicidal ideation from 0 (I don't have thoughts of killing myself) to 3 (I would kill myself if I had the chance) with higher scores indicating more severe suicidal ideation.
Measured: 40 minutes after the beginning of the infusion
Treatment durability measured by the Beck Scale for Suicidal Ideation (SSI5)
The durability of a treatment effect on suicidal ideation will be measured by SSI5 at 80 minutes, 120 minutes, 24 hours, and seven days post treatment start.
The first 5 questions of Beck Scale for Suicidal Ideation (SSI5) is a five item questionnaire scored from 0 to 10, with higher scores indicating more severe suicidal ideation.
Measured: 40, 80, 120 minutes after the beginning of the infusion as well as 24 hours and 7 days post enrollment
Treatment durability measured by the suicide item (#10) from the Montgomery-Asberg Depression Rating Scale (MADRS10)
The durability of a treatment effect on suicidal ideation will be measured by MADRS10 at 80 minutes, 120 minutes, 24 hours, and seven days post treatment start.
The MADRS is a 10 item, 6-point, depression scale. Item 10 rates suicidal ideation from 0 (Enjoys life or takes it as it comes), to 6 (Explicit plans for suicide when there is an opportunity. Active preparations for suicide) with higher scores indicating more severe suicidal ideation.
Measured: 40, 80, 120 minutes after the beginning of the infusion as well as 24 hours and 7 days post enrollment
Treatment efficacy measured by the suicide item (#9) from the Beck Depression Index (BDI9)
The durability of a treatment effect on suicidal ideation will be measured by BDI9 at 80 minutes, 120 minutes, 24 hours, and seven days post treatment start.
The Beck Depression Inventory is a 21 item depression questionnaire. Item 9 rates suicidal ideation from 0 (I don't have thoughts of killing myself) to 3 (I would kill myself if I had the chance) with higher scores indicating more severe suicidal ideation.
Measured: 40, 80, 120 minutes after the beginning of the infusion as well as 24 hours and 7 days post enrollment
Admission to Hospital
Proportion of patients who require hospital admission at the enrolment ED visit
Measured: Enrollment visit
Length of Stay in Hospital
The mean and standard deviation of length of hospital stay for patients admitted at the enrollment visit
Measured: 30 days post enrollment
ED revisits
Proportion of patients who have an ED visit(s) for mental health complaints within 30 days following enrolment
Measured: 30-days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Jan 2024
- Primary completion29 May 2024
- Study completion28 Jun 2024 (estimated)
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maala Bhatt, Children's Hospital of Eastern Ontario
- Investigators
- Tyrus Crawford, BA, Study director, CHEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366334
- Sponsor's protocol ID
- 23/02E
- Acronym
- KSI
- Status last verified
- Jun 2024
- First submitted
- 10 Apr 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schlegelmilch M, Plint AC, Barrowman N, Gray C, Crawford T, Kutcher SA, Bhatt M. Single dose IV ketamine for adolescent suicidal ideation in the emergency department: a pilot randomized trial. BMC Psychiatry. 2026 Apr 6;26(1):415. doi: 10.1186/s12888-026-08042-9.
PubMed 41937124