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Unknown statusEarly Phase 1

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

NCT05217706 · Rady Children's Hospital, San Diego

Closed to entry
Status
Not accepting participants
Early Phase 1
Phase
30
Target enrolment
1
Study sites
1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change in Beck Depression Inventory Depression sub-scale Score

    Measured over 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

12 Years to 18 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Rady Children's Hospital San DiegoSan DiegoCaliforniaUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05217706 on ClinicalTrials.gov →

Last updated in the registry 2023-02-16. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits