Study of IV Ketamine for Emergency Department Treatment of Adolescent Suicidal Ideation

NCT ID: NCT05468840

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-07-31

Brief 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. 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intravenous ketamine infusion

Participants in the intervention group will receive 0.5mg/kg of 1mg/mL intravenous ketamine (50 mg maximum) over 40 minutes.

Group Type: EXPERIMENTAL

Ketamine Hydrochloride

Intervention Type: DRUG

see study arm description

Intravenous normal saline infusion

Participants in the control group will receive 0.5mL/kg intravenous normal saline (50 ml maximum) over 40 minutes.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

see study arm description

Interventions

Ketamine Hydrochloride

see study arm description

Intervention Type: DRUG

Normal saline

see study arm description

Intervention Type: DRUG

Other Intervention Names

ketamine

Eligibility Criteria

Inclusion Criteria

1. Responds "yes" to ASQ questionnaire at triage, which asks; "Are you having thoughts of killing yourself right now?"

2. Moderate to severe suicidal ideation, defined as score ≥ 3 on the first 5 questions of the Beck Scale for Suicidal Ideation (SSI5)

3. Age 12 to 17 years, inclusive

4. Medically clear, as judged by the treating physician

5. Speaks English or French

Exclusion Criteria

1. Acute intoxication

2. Previously enrolled in the current study or another clinical trial

3. History of intellectual disability or autism spectrum disorder by patient/parent report

4. Active, or history of, psychosis or psychotic disorder

5. History of non-psychiatric neurologic disorder (e.g., epilepsy)

6. Any of the following contraindications to ketamine based on the drug monograph:

1. Known allergy or hypersensitivity to ketamine by patient history

2. History of cerebrovascular accident (stroke or aneurysm)

3. History of elevated intracranial pressure or idiopathic intracranial hypertension

4. Significant hypertension requiring daily medication

5. Severe cardiac decompensation

7. On a Form 1

8. Requires physical or chemical restraint

9. History of violence while in hospital

10. Assessment by a mental health practitioner during the current ED visit prior to study enrollment

11. Pregnant or breastfeeding

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ottawa

OTHER

Sponsor Role: lead

Responsible Party

Michael Schlegelmilch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHEO

Ottawa, Ontario, Canada

Countries

Canada

Central Contacts

Michael Schlegelmilch, MD, MPH

Role: CONTACT

mschlegelmilch@cheo.on.ca

1-613-737-7600

Maala Bhatt, MD, Msc

Role: CONTACT

mbhatt@cheo.on.ca

Facility Contacts

Maala Bhatt, MD

Role: primary

mbhatt@cheo.on.ca

References

Schlegelmilch M, Plint AC, Barrowman N, Gray C, Bhatt M. Intravenous ketamine for emergency department treatment of suicidal ideation in a paediatric population: protocol for a double-blind, randomised, placebo-controlled, parallel-arm pilot trial (KSI study). BMJ Open. 2024 Jul 5;14(7):e085681. doi: 10.1136/bmjopen-2024-085681.

Reference Type: DERIVED

PMID: 38969374 (View on PubMed)

Other Identifiers

0000001

Identifier Type: -

Identifier Source: org_study_id