RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Low-Dose Intravenous Ketamine for Adolescents With Depression and Suicidal Ideation in the Emergency Department: A Randomized Placebo-Controlled Trial

Quick Facts

Study Start:2022-03-01
Study Completion:2024-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05217706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Determined, based upon medical and social work evaluation, to require inpatient psychiatric admission without further need for medical diagnostic evaluation and treatment.
  2. * Treatment-resistant depression (defined as failure of response to trials of at least 2 antidepressant courses, each of at least 4 weeks' duration)
  3. * Parent/guardian available for consent (in person or by phone)
  1. * 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
  2. * Aggressive behavior, homicidal ideation
  3. * Altered mental status
  4. * Pregnancy or breastfeeding,
  5. * Currently receiving (or receipt within last 24 hours) medication acting on NMDA receptor system (lamotrigine, dextromethorphan, methadone, clarithromycin, amantadine)
  6. * Incomplete medical evaluation or stabilization
  7. * Contraindications to or anaphylaxis or prior adverse reaction to Ketamine
  8. * No caregiver available
  9. * In custody of a law enforcement agency

Contacts and Locations

Study Contact

Tatyana Vayngortin, MD
CONTACT
8589668036
tvayngortin@rchsd.org

Study Locations (Sites)

Rady Children's Hospital San Diego
San Diego, California, 92123
United States

Collaborators and Investigators

Sponsor: Rady Children's Hospital, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-01
Study Completion Date2024-01-01

Study Record Updates

Study Start Date2022-03-01
Study Completion Date2024-01-01

Terms related to this study

Keywords Provided by Researchers

  • emergency department
  • adolescent
  • ketamine

Additional Relevant MeSH Terms

  • Depression
  • Suicidal Ideation