Phase 2
N=180
Oxytocin to Treat PTSD
PTSD
Bottom Line
View on ClinicalTrials.gov: NCT04228289 ↗Enrolled (actual)
180
Serious AEs
0.6%
Results posted
Mar 2026
Primary outcome: Primary: Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated — -10.1; -12 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oxytocin (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated |
-10.1; -12 | — |
| PRIMARY Change in Post Traumatic Stress Disorder Symptom Severity - Self Report |
-19.4; -25.2 | — |
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
Eligibility Criteria
Inclusion Criteria
- Veteran
- Any race or ethnicity
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments (> 26 on the Mini Mental Status Exam)
- Meet DSM-5 diagnostic criteria for current (i.e., past 6 months) PTSD (assessed via the CAPS-5)
- participants may also meet criteria for a mood disorder (except bipolar affective disorder, see Exclusion Criteria)
- anxiety disorders (e.g. panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder)
- Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation
Exclusion Criteria
- Meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders, or with current suicidal or homicidal ideation and intent
- those participants will be referred clinically
- Participants who present a serious suicide risk or are likely to require hospitalization during the study
- Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks
- Pregnancy or breastfeeding for women
Data sourced from ClinicalTrials.gov (NCT04228289). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.