Status:
UNKNOWN
Low-Dose Intravenous Ketamine for Adolescents With Depression and Suicidal Ideation in the Emergency Department
Lead Sponsor:
Rady Children's Hospital, San Diego
Collaborating Sponsors:
University of California, San Diego
Conditions:
Depression
Suicidal Ideation
Eligibility:
All Genders
12-18 years
Phase:
EARLY_PHASE1
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 depress...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05217706
Start Date
March 1 2022
End Date
January 1 2024
Last Update
February 16 2023
Active Locations (1)
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1
Rady Children's Hospital San Diego
San Diego, California, United States, 92123