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Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics

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ClinicalTrials.gov Identifier: NCT04955470
Recruitment Status : Not yet recruiting
First Posted : July 8, 2021
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Quynh Doan, University of British Columbia

Tracking Information
First Submitted Date  ICMJE June 21, 2021
First Posted Date  ICMJE July 8, 2021
Last Update Posted Date September 30, 2021
Estimated Study Start Date  ICMJE November 1, 2021
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2021)
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours, 7-, 14-, 21-, and 28 days ]
    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: 24 hours, 7-, 14-, 21-, and 28 days ]
    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: 24 hours, 7-, 14-, 21-, and 28 days ]
    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.
  • Blinding assessment [ Time Frame: 90 minutes post infusion ]
    The proportion of participants and research personnel that correctly identify treatment arm allocation.
  • Enrolment rate [ Time Frame: 28-days ]
    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.
  • Demographics [ Time Frame: 28-days ]
    Demographics of eligible patients who decline to participate in the study.
  • Drug reactions [ Time Frame: 28-days ]
    Incidence and frequency of side effects and adverse events.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics
Official Title  ICMJE Ketamine Infusion for Rapid Reduction of Suicidality in Pediatrics: a Pilot Randomized Controlled Trial
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Suicidal Ideation
Intervention  ICMJE
  • Drug: Ketamine Injectable Solution
    A 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg.
  • Drug: Midazolam Injectable Solution
    A 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg.
  • Drug: Normal Saline 0.9% Injectable Solution
    A 0.9% normal saline solution will be infused over a 40 minute period.
Study Arms  ICMJE
  • Experimental: Intravenous ketamine
    Infusion of 0.5 mg/kg of ketamine, at maximum dose of 40 mg, over 40 minutes.
    Intervention: Drug: Ketamine Injectable Solution
  • Active Comparator: Intravenous midazolam
    Infusion of 0.03 mg/kg of midazolam, at maximum dose of 2 mg, over 40 minutes.
    Intervention: Drug: Midazolam Injectable Solution
  • Placebo Comparator: Intravenous saline
    Infusion of 0.9% saline over 40 minutes.
    Intervention: Drug: Normal Saline 0.9% Injectable Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2021)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2023
Estimated Primary Completion Date May 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

The study will enroll children and adolescents presenting with SI in the paediatric ED.

Inclusion Criteria:

  1. 10 to 17 years of age
  2. Respond "yes" to either question 1 (Passive Ideation) or 2 (Active Ideation) on the C-SSRS
  3. Respond "yes" to either questions 3 (Method), 4 (Intent), or 5 (Plan) on the C-SSRS
  4. Deemed acceptable and appropriate for admission to the on-site Child and Adolescent Psychiatry Emergency (CAPE) unit by a pediatric psychiatrist
  5. Normal vital signs for age and a normal neurological exam (no focal deficits or abnormalities), as per attending clinician

Exclusion Criteria:

  1. History of benzodiazepine or ketamine use in the past 5 years
  2. Previous diagnosis of schizophrenia or active psychosis as per the treating physician
  3. Clinically unstable, requires resuscitation or admission to a medical ward for stabilizing therapy (i.e., intensive care unit.)
  4. Intoxicated or delirious
  5. Suspected or confirmed pregnancy
  6. Taking medications that may contraindicate the use of ketamine
  7. Known allergy or sensitivity to ketamine or ketamine-like compounds
  8. Neuro-cognitive impairment that precludes informed consent, assent, or ability to self-report pain and satisfaction
  9. Inability to understand spoken and/or written English without the use of an interpreter
  10. Previous enrollment in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Karly Stillwell (604) 875-2345 ext 3691 kstillwell@bcchr.ca
Contact: Tatsuma Hind, BSc txhind@student.ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04955470
Other Study ID Numbers  ICMJE H21-01433
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Quynh Doan, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Quynh Doan, PhD MHSc MD University of British Columbia
PRS Account University of British Columbia
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP