Oxytocin to Treat PTSD

NCT04228289 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: MHBB-001-19S
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

PTSD

Keywords

PTSD; Veterans; Oxytocin; Mental Health; Psychophysiology

Outcome Measures

Primary Outcomes (2)

• Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated

  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).

  From baseline to of Treatment (10 weeks)

• Change in Post Traumatic Stress Disorder Symptom Severity - Self Report

  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).

  From baseline to end of Treatment (10 weeks)

Study Arms (2)

Oxytocin

EXPERIMENTAL

40 IU intranasal oxytocin

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

intranasal saline spray

Other: Placebo

Interventions

Oxytocin DRUG

40 IU intranasal spray

Also known as: Pitocin

Oxytocin

Placebo OTHER

matching intranasal spray

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• San Francisco VA Health Care System: collaborator

Study Sites (2)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121, United States

Location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location

Related Publications (1)

• Flanagan JC, Mitchell JM, Baker NL, Woolley J, Wangelin B, Back SE, McQuaid JR, Neylan TC, Wolfe WR, Brady KT. Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial. Contemp Clin Trials. 2020 Aug;95:106074. doi: 10.1016/j.cct.2020.106074. Epub 2020 Jun 16.

  PMID: 32561468 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychological Well-Being

Interventions

Oxytocin; Sodium Chloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Stacey Sellers
• Organization: Medical University of South Carolina

sellersst@musc.edu

843-792-5807

Study Officials

• Julianne Christina Flanagan, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 manner to one of two drug conditions

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 14, 2020
• Study Start: January 1, 2021
• Primary Completion: February 28, 2025
• Study Completion: August 31, 2025
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)