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Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents

NCT04592809 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-28

No results posted yet for this study

Summary

This project aims to examine the signal of efficacy of ketamine, a rapidly acting medication shown to decrease suicidality in adults in as short as hours or days, as opposed to weeks.

The study design is a double-blind, randomized, active-control trial of adolescents (ages 13-18 years) with recent suicidal behaviors (suicide attempt or increased suicidal ideation). All participants must be receiving standard of care treatment which may range broadly from both outpatient and inpatient programs which include clinically indicated psychosocial and/or psychopharmacological treatments. Ketamine/midazolam treatment will occur twice weekly during the first two weeks of the study, followed by weekly assessments through week 12.

Conditions

  • Suicide, Attempted
  • Suicide and Depression
  • Suicide Threat

Interventions

DRUG

Ketamine Hydrochloride

infused over a 40 minute period

DRUG

Midazolam Hydrochloride

infused over a 40 minute period

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

Principal Investigators

  • Madhukar Trivedi, MD · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2025-07-01
Completion
2025-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04592809 on ClinicalTrials.gov