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NCT04613453 · ClinicalTrials.gov registry record · Phase 2
Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine
A Phase 2 study, sponsored by Yale University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT04613453 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 12 participants.
The verdict
NCT04613453, a Phase 2 study, was terminated before completion, sponsored by Yale University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo (midazolam) in adolescents who have treatment resistant depression and a recent history of a suicide event (defined as a suicide attempt, emergency room evaluation for suicidal thinking, or a transition to inpatient care for suicidality in the past 120 days). The primary objective of this study is to determine whether ketamine reduces suicidal ideation (as measured via the C-SSRS, recent ideation scale) relative to an active control, midazolam, 48-hours after first administration in adolescents with TRD at high suicide risk.
Interventions
- DRUG Ketamine Infusion
- DRUG Midazolam Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2024-12-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04613453
The ClinicalTrials.gov registry entry for NCT04613453 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketamine Infusion is the first listed.
NCT04613453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04613453 about?
NCT04613453 is a clinical study titled "Reducing Adolescent Suicide Risk: Safety, Efficacy, and Connectome Phenotypes of Intravenous Ketamine". The purpose of this study is to determine if intravenous ketamine reduces suicidal thinking compared to an active placebo (midazolam) in adolescents who have treatment resistant depression and a recent history of a suicide event (defined as a suicide attempt, emergency room evaluation for suicidal t...
What is the current status of trial NCT04613453?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2022-01-21. Estimated completion is 2024-12-03.
What interventions are being tested in trial NCT04613453?
The interventions under investigation include: Ketamine Infusion (DRUG), Midazolam Infusion (DRUG).
Who is sponsoring clinical trial NCT04613453?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
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