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NCT04032301 · ClinicalTrials.gov registry record · Phase 1
Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans
A Phase 1 study, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT04032301: Completed Phase 1 study, sponsored by University of Minnesota.
NCT04032301 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04032301, a Phase 1 study, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk than individuals with only one of these disorders. Ketamine given as repeated infusions has been shown to be effective in rapidly reducing PTSD and MDD symptoms in treatment resistant PTSD+MDD individuals. However, knowledge about the mechanisms underlying comorbid PTSD and MDD remain limited. The purpose of this study is to use repeated ketamine infusions as a probe to validate a model of PTSD+MDD that focuses on neuroanatomy and executive functioning.
Primary Outcome
Change in major depressive disorder symptoms over the course of the intervention.
Interventions
- DRUG Ketamine
- OTHER Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2024-11-10 |
| Phase | Phase 1 |
What the finished NCT04032301 record still lists
NCT04032301 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT04032301 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04032301 about?
NCT04032301 is a clinical study titled "Repeated Ketamine Infusions for Comorbid PTSD and MDD in Veterans". Co-occurring post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) is the most common response to trauma; it is associated with poor clinical outcomes and substantial human disability. Veterans with both PTSD and MDD (PTSD+MDD) have been shown to be at much greater suicidal risk ...
What is the current status of trial NCT04032301?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2019-09-30. Estimated completion is 2024-11-10.
What interventions are being tested in trial NCT04032301?
The interventions under investigation include: Ketamine (DRUG), Normal Saline (OTHER).
Who is sponsoring clinical trial NCT04032301?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04032301's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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