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

ConditionsSuicidal Ideation Suicidal Ideas

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-17

SponsorChildren's Hospital of Eastern Ontario

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Ketamine Hydrochloride
Drug
See arm description
Normal saline
Drug
See arm description

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: KetamineExperimental treatment 1 intervention

Group B: Normal SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

Baseline

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Baseline

Other outcomes

Safety Outcome 1: Clinically significant tachycardia

Present at 120 minutes post infusion and requires intervention by the treating team

Time frame

Enrollment visit

Safety Outcome 2: Clinically significant hypertension

Present at 120 minutes post infusion and requires intervention by the treating team

Time frame

Enrollment visit

Safety Outcome 3: Vomiting

Vomiting during or after the infusion

Time frame

Enrollment visit

Safety Outcome 4: Dissociation

Clinician-Administered Dissociative States Scale (CADSS; minimum score 0, maximum score 24) - total score of 6 or more OR 4 on any single question AND clinically dissociated

Time frame

During the infusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Eastern Ontario

Lead sponsor

Source ClinicalTrials.gov

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