UnknownEarly Phase 1ketamine

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

NCT ID

NCT05217706

Target Enrollment

30 participants

Start Date

2022-03-01

Est. Completion

2024-01-01

About This Study

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.

Conditions Studied

DepressionSuicidal Ideation

Interventions

•Ketamine
•normal Saline

Eligibility

Age:12 Years - 18 Years

Healthy Volunteers:Yes

View full eligibility 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

Study Locations (1)

Rady Children's Hospital San Diego