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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: Clinical Trial Phase 2 study, sponsored by Yale University.
NCT04613453 is a Phase 2 study that was terminated before completion, run by Yale University. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). Total score ranges for suicidal ideation from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent). Total score ranges for suicidal beha
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 |
Why NCT04613453 stopped before completion
NCT04613453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine Infusion is the first listed.
NCT04613453 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04613453's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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