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Low-Dose Intravenous Ketamine for Adolescents With Depression and Suicidal Ideation in the Emergency Department

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ClinicalTrials.gov Identifier: NCT05217706
Recruitment Status : Recruiting
First Posted : February 1, 2022
Last Update Posted : March 21, 2022
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Tanya Vayngortin, Rady Children's Hospital, San Diego

Brief Summary:
The goal of this study is to test whether a single low-dose of IV ketamine given in the emergency department to adolescents with treatment-resistant depression and suicidal ideation can reduce depression symptoms and suicidal thoughts compared to placebo. Participants will complete depression scales at baseline, and 1 hour, 3 hours, 1 day, 3 days, and 7 days after receiving the treatment.

Condition or disease Intervention/treatment Phase
Depression Suicidal Ideation Drug: Ketamine Drug: normal Saline Early Phase 1

Detailed Description:

This study will be a double-blinded, randomized, placebo-controlled trial. Study investigators and trained research assistants (RAs) will identify eligible participants from the electronic ED tracking board based on inclusion criteria, and will confirm eligibility with the treating physician. After a patient has been evaluated by nursing, physician, and social worker and has been determined to require inpatient psychiatric admission, the patient and parent/guardian will be approached for the study. A parent/guardian must be available in person or by phone to provide consent, and the adolescent will provide assent. The RA or investigator will collect demographic data and psychiatric history from the electronic medical record to verify eligibility criteria, and will confirm with the treating physician that the patient can participate in the study. The RA or investigator will provide the patient self-administered scales, including the Suicidal Ideation Questionnaire and the Beck Depression, Anxiety, and Self-Concept Scales.

After the patient has assented and parent/guardian has consented to participation in the study, a study physician will initiate the electronic study order set. The Investigational Drug Service Pharmacy at RCHSD will dispense either ketamine 0.2 mg/kg (minimum 10 mg, maximum 20 mg) or normal saline in the same volume in identically-appearing syringe, based upon a pre-determined randomization scheme kept only in the pharmacy. The study will be blinded to ordering and treating providers, as well as the RA and nurse. The investigators will use an online randomization tool, and randomization will be even between the two groups. S An ED nurse will place an IV catheter if the patient does not already have one, and will record heart rate, blood pressure, respiratory rate, oxygen saturation immediately before the infusion and 5 minutes after. The medication will be given over 2 minutes by a nurse, who will remain in the room for 5 minutes after infusion. The patient will remain on pulse oximeter for 30 minutes. The RA or study investigator will administer a post-infusion survey to document any adverse effects and will record pre- and post-infusion vital signs 5 minutes after infusion. The IV catheter will then be removed unless required for another clinical indication as determined by the treating physician. After the 30 minute monitoring period, the patient will resume standard ED care and can be transferred to the psychiatric ED or CAPS whenever the bed is available. The RA or investigator will administer follow up depression and SI scales after 1 hour, 3 hours, 1 day, 3 days, and 7 days either in the psychiatric ED or CAPS, or by telephone if the patient has been discharged.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: double-blinded randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The enroller, treating provider, and patient are masked. Only the pharmacist will be un-masked, as they are preparing the medication or placebo.
Primary Purpose: Treatment
Official Title: Low-Dose Intravenous Ketamine for Adolescents With Depression and Suicidal Ideation in the Emergency Department: A Randomized Placebo-Controlled Trial
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Treatment
This group will be given ketamine 0.2mg/kg
Drug: Ketamine
The treatment group will receive Ketamine 0.2mg/kg IV once

Placebo Comparator: Placebo
This group will be given normal saline in matched syringe
Drug: normal Saline
The placebo group will receive normal saline IV in a matched syringe




Primary Outcome Measures :
  1. Change in Beck Depression Inventory Depression sub-scale Score [ Time Frame: 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment ]
    Beck depression inventory score, 0-20 (higher score associated with worse depression)


Secondary Outcome Measures :
  1. Change in Beck Depression Inventory anxiety sub-scale score [ Time Frame: 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment ]
    Depression sub-score, 0-20 (higher score associated with worse anxiety)

  2. Change in Beck Depression Inventory self-concept sub-scale score [ Time Frame: 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment ]
    Depression sub-score, 0-20 (higher score associated with worse self-concept)

  3. Change in Suicidal Ideation Questionnaire score [ Time Frame: 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment ]
    Suicidal Ideation score, 0-120 (higher score associated with higher suicide risk)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Determined, based upon medical and social work evaluation, to require inpatient psychiatric admission without further need for medical diagnostic evaluation and treatment.
  • Treatment-resistant depression (defined as failure of response to trials of at least 2 antidepressant courses, each of at least 4 weeks' duration)
  • Parent/guardian available for consent (in person or by phone)

Exclusion Criteria:

  • Any of the following co-existing diagnoses: primary psychotic disorder (schizophrenia, schizoaffective) autism spectrum disorder, developmental delay/intellectual disability, substance abuse disorder within the last 6 months
  • Aggressive behavior, homicidal ideation
  • Altered mental status
  • Pregnancy or breastfeeding,
  • Currently receiving (or receipt within last 24 hours) medication acting on NMDA receptor system (lamotrigine, dextromethorphan, methadone, clarithromycin, amantadine)
  • Incomplete medical evaluation or stabilization
  • Contraindications to or anaphylaxis or prior adverse reaction to Ketamine
  • No caregiver available
  • In custody of a law enforcement agency

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05217706


Contacts
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Contact: Tatyana Vayngortin, MD 8589668036 tvayngortin@rchsd.org

Locations
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United States, California
Rady Children's Hospital San Diego Recruiting
San Diego, California, United States, 92123
Contact: Tatyana Vayngortin         
Sponsors and Collaborators
Rady Children's Hospital, San Diego
University of California, San Diego
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Responsible Party: Tanya Vayngortin, Assistant Clinical Professor, Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier: NCT05217706    
Other Study ID Numbers: 800170
First Posted: February 1, 2022    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study data will be published in the future

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tanya Vayngortin, Rady Children's Hospital, San Diego:
emergency department
adolescent
ketamine
Additional relevant MeSH terms:
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Emergencies
Depression
Depressive Disorder
Suicidal Ideation
Behavioral Symptoms
Mood Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Suicide
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action