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NCT04378426 · ClinicalTrials.gov registry record · Phase 2
Nitrous Oxide for PTSD
A Phase 2 study, sponsored by VA Office of Research and Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04378426: Clinical Trial Phase 2 study, sponsored by VA Office of Research and Development.
NCT04378426 is a Phase 2 study that was terminated before completion, run by VA Office of Research and Development. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04378426, a Phase 2 study, was terminated before completion, sponsored by VA Office of Research and Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Post-traumatic stress disorder (PTSD) seriously disrupts the lives of many Veterans. Current first-line treatments, serotonin reuptake inhibitors or prolonged exposure therapy, take weeks to months to bring meaningful improvement, leaving Veterans experiencing prolonged suffering. A promising new treatment approach for rapidly reducing PTSD symptoms is nitrous oxide, an inhalation anesthetic and putative glutamate modulator that diminishes depression symptoms within 1 day and has limited side effects. If shown to be similarly effective in PTSD, nitrous oxide may add dramatically to the treatment armamentarium by bringing rapid symptom decrease before longer-term therapies take hold. The proposed projects test the efficacy of nitrous oxide in relieving Veteran's PTSD symptoms and, in parallel, explore how nitrous oxide may modify cognitive and pain outcomes.
Primary Outcome
Improvement in PTSD severity is measured by the Clinician Administered PTSD Scale DSM-5 (CAPS-5). It measures frequency and intensity of PTSD-related symptoms. For the CAPS-5 the minimum units are 0 and maximum units are 80. The higher the number on the CAPS-5, the more severe the PTSD symptoms. Response is defined as a change in the CAPS-5 of at least 12 points, which represents meaningful improvement in clinical PTSD symptoms.
Interventions
- DRUG Midazolam
- DRUG Saline
- DRUG Oxygen
- DRUG Nitrous Oxide
- DRUG Nitrogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 2 |
Why NCT04378426 stopped before completion
NCT04378426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Midazolam is the first listed.
NCT04378426 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04378426 about?
NCT04378426 is a clinical study titled "Nitrous Oxide for PTSD". Post-traumatic stress disorder (PTSD) seriously disrupts the lives of many Veterans. Current first-line treatments, serotonin reuptake inhibitors or prolonged exposure therapy, take weeks to months to bring meaningful improvement, leaving Veterans experiencing prolonged suffering. A promising new tr...
What is the current status of trial NCT04378426?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2021-10-07. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04378426?
The interventions under investigation include: Midazolam (DRUG), Saline (DRUG), Oxygen (DRUG), Nitrous Oxide (DRUG), Nitrogen (DRUG).
Who is sponsoring clinical trial NCT04378426?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04378426's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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