Trial · NCT04228289

Oxytocin to Treat PTSD

NCT04228289, Phase 2, Completed, VA Office of Research and Development; results first posted 2026-03-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Oxytocin to Treat PTSD. Trials, record NCT04228289. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04228289

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Oxytocin to Treat PTSD
NCT number: NCT04228289
Status: Completed
Phases: Phase 2
Enrollment: 180 participants, actual
Lead sponsor: VA Office of Research and Development
Conditions: PTSD
Interventions: Oxytocin, Placebo
First posted: 2020-01-14
Last updated: 2026-03-11
Results first posted: 2026-03-11

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	From baseline to of Treatment (10 weeks)	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 outcomes (less severe PTSD).
Primary	Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	From baseline to end of Treatment (10 weeks)	Change in Post Traumatic Stress Disorder (PTSD) symptom severity as measured by the Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition \[DSM-5\](PCL-5) for self-reported symptoms. The PCL-5 is a 20-item self-report measure that assesses the 20 symptoms of PTSD. The rating scale is 0-4 for each symptom/item, and overall scores range from 0-80, with lower scores representing better outcomes (less severe PTSD).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	From baseline to of Treatment (10 weeks)	Analysis population includes participants who completed treatment.	units on a scale	MEAN
PRIMARY	Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	From baseline to end of Treatment (10 weeks)	Population analysis includes participants who completed the treatment phase.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	Oxytocin	-10.1	Standard Deviation 11.8	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated	Placebo	-12	Standard Deviation 12.8	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	Oxytocin	-19.4	Standard Deviation 18	units on a scale
Change in Post Traumatic Stress Disorder Symptom Severity - Self Report	Placebo	-25.2	Standard Deviation 18	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Oxytocin	92
Overall Study	STARTED	Placebo	88
Overall Study	COMPLETED	Oxytocin	68
Overall Study	COMPLETED	Placebo	68
Overall Study	NOT COMPLETED	Oxytocin	24
Overall Study	NOT COMPLETED	Placebo	20

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Upper Respiratory Infection	Infections and infestations	Oxytocin	12	92	13
other	Upper Respiratory Infection	Infections and infestations	Placebo	8	88	8
other	Headache	Nervous system disorders	Oxytocin	7	92	8
other	Headache	Nervous system disorders	Placebo	6	88	9
other	Knee Pain	Musculoskeletal and connective tissue disorders	Oxytocin	6	92	6
other	Knee Pain	Musculoskeletal and connective tissue disorders	Placebo	0	88	0
other	Migraine	Nervous system disorders	Oxytocin	5	92	6
other	Migraine	Nervous system disorders	Placebo	2	88	2
other	COVID-19	Infections and infestations	Oxytocin	2	92	2
other	COVID-19	Infections and infestations	Placebo	8	88	8

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Oxytocin	0	92
Total, all-cause mortality	Placebo	0	88
Total, other adverse events	Oxytocin	28	92
Total, other adverse events	Placebo	23	88
Total, serious adverse events	Oxytocin	1	92
Total, serious adverse events	Placebo	0	88

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32561468	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Oxytocin vs Placebo: deaths from any cause	Trial comparisons
Oxytocin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04228289

GET https://conductscience.org/api/trials/v1/NCT04228289/registered

API reference For AI assistants