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NCT04592809 · ClinicalTrials.gov registry record · Phase 3
Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents
A Phase 3 study of Suicide, Attempted and Suicide Threat, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04592809: Completed Phase 3 study of Suicide, Attempted and Suicide Threat, sponsored by University of Texas Southwestern Medical Center.
NCT04592809 is a Phase 3 study of Suicide, Attempted and Suicide Threat that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants, below the 378-participant average among 36 other Suicide, Attempted trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04592809, a Phase 3 study of Suicide, Attempted and Suicide Threat, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Concise Health Risk Tracking Clinician-Rated Behavior Module (CHRT-C) will be used to identify suicidal events. The CHRT-C consists of nine clinician-rated yes/no items about specific behaviors (i.e., suicidal ideation, suicidal attempt, preparatory acts, non-suicidal self-injury (NSSI), other injuries, etc.). At the initial administration, this instrument captures lifetime information; at subsequent administrations, it will capture information since the last visit.
Conditions Studied
Interventions
- DRUG Ketamine Hydrochloride
- DRUG Midazolam Hydrochloride
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 3 |
What the finished NCT04592809 record still lists
NCT04592809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 378-participant average among 36 other Suicide, Attempted trials with a reported enrollment target (87% lower).
The record links to 3 conditions, with Suicide, Attempted appearing as the primary indexed condition, and to 2 interventions - of which Ketamine Hydrochloride is the first listed.
NCT04592809 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04592809 about?
NCT04592809 is a clinical study titled "Ketamine Versus Midazolam for Recurrence of Suicidality in Adolescents". 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 ...
What is the current status of trial NCT04592809?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2022-10-03. Estimated completion is 2025-08-31.
What conditions does trial NCT04592809 study?
This clinical trial studies the following conditions: Suicide, Attempted, Suicide Threat, Suicide and Depression.
What interventions are being tested in trial NCT04592809?
The interventions under investigation include: Ketamine Hydrochloride (DRUG), Midazolam Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04592809?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04592809 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Suicide, Attempted
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04592809's enrollment target sits among peer trials
50 33rd of 36 higher than 4 of 36 other Suicide, Attempted trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicide, Attempted trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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