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

NCT05217706 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 800170
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

emergency department; adolescent; ketamine

Outcome Measures

Primary Outcomes (1)

• Change in Beck Depression Inventory Depression sub-scale Score

  Beck depression inventory score, 0-20 (higher score associated with worse depression)

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

Secondary Outcomes (3)

• Change in Beck Depression Inventory anxiety sub-scale score

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

• Change in Beck Depression Inventory self-concept sub-scale score

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

• Change in Suicidal Ideation Questionnaire score

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

Study Arms (2)

Treatment

EXPERIMENTAL

This group will be given ketamine 0.2mg/kg

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

This group will be given normal saline in matched syringe

Drug: normal Saline

Interventions

Ketamine DRUG

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

Treatment

normal Saline DRUG

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

Placebo

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rady Children's Hospital, San Diego: lead
• University of California, San Diego: collaborator

Study Sites (1)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Depression; Suicidal Ideation; Emergencies

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Tatyana Vayngortin, MD

CONTACT

8589668036; tvayngortin@rchsd.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The enroller, treating provider, and patient are masked. Only the pharmacist will be un-masked, as they are preparing the medication or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Model Details: double-blinded randomized controlled trial

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: February 1, 2022
• Study Start: March 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)