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NCT04228289 · ClinicalTrials.gov registry record · Phase 2
Oxytocin to Treat PTSD
A Phase 2 study of PTSD, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 2
- Study locations
NCT04228289: Completed Phase 2 study of PTSD, sponsored by VA Office of Research and Development.
NCT04228289 is a Phase 2 study of PTSD that has completed, run by VA Office of Research and Development. The registered enrollment target is 180 participants, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228289, a Phase 2 study of PTSD, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 2
- Study locations
Study Summary
Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans. Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD. However, approximately one-third of Veterans fail to receive an adequate dose of treatment because they prematurely drop out of PE therapy. There is also room to improve PE treatment outcomes. Consistent with the VA Office of Research and Development initiative to develop effective treatments for PTSD, the proposed randomized clinical trial will examine the ability of oxytocin (as compared with placebo) combined with PE to reduce PTSD symptom severity, improve the rate of PTSD symptom reduction, and to enhance PE treatment retention and adherence. This two-site study will leverage the investments made in the nationwide rollout off PE therapy and has the potential to significantly improve mental health care among Veterans, advance the science in this area, and identify mechanisms underlying positive PTSD treatment response. Participants may choose to complete this research study via home-based telemedicine (HBT) care (i.e. service delivery to patients in their homes using consumer friendly, video-conferencing technology). HBT sessions will be delivered via standard desk, laptop computer, tablet, or smartphone using VA approved applications. All procedures that take place via telemedicine will be performed and completed as though they were in-person/in-office
Primary Outcome
Change in Post Traumatic Stress Disorder symptom severity as measured by Clinician Administered Post Traumatic Stress Disorder (PTSD) Scale (CAPS-5) for clinician-rated posttraumatic stress symptoms. The CAPS-5 is a 30-item structured interview. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 PTSD symptoms, each with severity scores ranging from 0-4. The overall total severity score for CAPS-5 ranges from 0-80, with lower scores representing better outcom
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Oxytocin
Study Locations (2)
California
- San Francisco VA Medical Center, San Francisco, CA - San Francisco
South Carolina
- Ralph H. Johnson VA Medical Center, Charleston, SC - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 2 |
What the finished NCT04228289 record still lists
NCT04228289 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 301-participant average among 154 other PTSD trials with a reported enrollment target (40% lower).
The record links to 1 condition, with PTSD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04228289 reports a single indexed study location in California, South Carolina.
Frequently Asked Questions
What is clinical trial NCT04228289 about?
NCT04228289 is a clinical study titled "Oxytocin to Treat PTSD". Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans. Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD. However, approximately one-third of Veterans fail to receive an adequate dose of treatment because they prematu...
What is the current status of trial NCT04228289?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2021-01-01. Estimated completion is 2025-08-31.
What conditions does trial NCT04228289 study?
This clinical trial studies the following conditions: PTSD.
What interventions are being tested in trial NCT04228289?
The interventions under investigation include: Placebo (OTHER), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT04228289?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228289 being conducted?
This trial has 2 study locations across California, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for PTSD
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04228289's enrollment target sits among peer trials
180 32nd of 154 higher than 120 of 154 other PTSD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PTSD 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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Induction of Dreaming With EEG and Anesthesia for Post-traumatic Stress Disorder
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Glecaprevir/Pibrentasvir for Post-traumatic Stress Disorder
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Safety and Efficacy of Cannabidiol (CBD) for Symptoms of PTSD in Adults
RECRUITING · Phase 2
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