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NCT06228391 · ClinicalTrials.gov registry record · Phase 2
Ketamine Treatment for PTSD and MDD in TBI
A Phase 2 study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT06228391: Clinical Trial Phase 2 study, sponsored by Minneapolis Veterans Affairs Medical Center.
NCT06228391 is a Phase 2 study that has not yet begun recruiting, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06228391, a Phase 2 study, has not yet begun recruiting, sponsored by Minneapolis Veterans Affairs Medical Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are: * Efficacy of ketamine to reduce symptoms of depression and/or PTSD * Safety of ketamine to treat depression and/or PTSD in TBI Participants will be randomly assigned to receive either ketamine or midazolam (active placebo) twice a week for 3 weeks. During participation, subjects will be interviewed, have lab tests, and complete rating scales, and questionnaires.
Primary Outcome
Total score on the Montgomery- Åsberg Depression Rating Scale , a semi- structured 10-item scale. Range 0-60. Higher values represent worse outcomes. The total score is obtained by summing the severity score of each item.
Interventions
- DRUG Midazolam
- DRUG IV ketamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-03 |
| Est. Completion | 2027-03 |
| Phase | Phase 2 |
What is known before NCT06228391 opens enrollment
NCT06228391 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Midazolam is the first listed.
NCT06228391 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06228391 about?
NCT06228391 is a clinical study titled "Ketamine Treatment for PTSD and MDD in TBI". The goal of this clinical trial is to examine the use of sedative ketamine to treat depression and post-traumatic stress disorder (PTSD) in Veterans with mild to moderate traumatic brain injury (TBI). The main questions it aims to answer are: * Efficacy of ketamine to reduce symptoms of depression ...
What is the current status of trial NCT06228391?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2024-03. Estimated completion is 2027-03.
What interventions are being tested in trial NCT06228391?
The interventions under investigation include: Midazolam (DRUG), IV ketamine (DRUG).
Who is sponsoring clinical trial NCT06228391?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06228391's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 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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