Recruiting
Early Phase 1

Ketamine

Sponsor:

Rady Children's Hospital, San Diego

Code:

NCT05217706

Conditions

Depression

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

Interventions

Ketamine

normal Saline

Study Details

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.

Conditions

Depression

Suicidal Ideation

Study ID

NCT05217706

Start date

Mar 1, 2022

Status verified date

Feb, 2023

Completion date

Jan 1, 2024

Anticipated

Primary completion date

Jan 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Accepted

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 Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

This group will be given ketamine 0.2mg/kg

placebo comparator: Placebo

This group will be given normal saline in matched syringe

Interventions

Ketamine

The treatment group will receive Ketamine 0.2mg/kg IV once

normal Saline

The placebo group will receive normal saline IV in a matched syringe

Primary outcome measure

  • Change in Beck Depression Inventory Depression sub-scale Score [ Time Frame: 1 hour, 3 hours, 1 day, 3 days, 7 days after treatment ]

Central Contacts and Locations

Central contacts

Tatyana Vayngortin, MD

8589668036tvayngortin@rchsd.org

Locations

Rady Children's Hospital San Diego

Recruiting

San Diego, California, United States, 92123

More Information

Sponsor

Rady Children's Hospital, San Diego

Last update posted

Feb 16, 2023

Last verified

Feb, 2023

Keywords

  • emergency department
  • adolescent
  • ketamine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rady Children's Hospital, San Diego on 2023-02-16.