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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin to Treat PTSD

NCTNCT04228289 (opens ClinicalTrials.gov in a new tab)Other idMHBB-001-19S
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
180 participants (actual)
Sponsor
VA Office of Research and Development · Fed
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
1 Jan 2021
Primary completion
28 Feb 2025
Completion
31 Aug 2025
First posted
14 Jan 2020
Last update posted
11 Mar 2026
Conditions
PTSD

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023202420252026
  1. Ph 2

    Oxytocin to Treat PTSD

    NCT04228289

    1 Jan 2021 to 31 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • OxytocinDrug
  • PlaceboOther

Arms2

  • Experimental

    Oxytocin

    40 IU intranasal oxytocin

  • Placebo comparator

    Placebo

    intranasal saline spray

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated

    Time frame · From baseline to of Treatment (10 weeks)

    Registry description

    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).

  2. Change in Post Traumatic Stress Disorder Symptom Severity - Self Report

    Time frame · From baseline to end of Treatment (10 weeks)

    Registry description

    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).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· From baseline to of Treatment (10 weeks)

Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated

GroupValue (units on a scale)Spread
Oxytocin-10.111.8
Placebo-1212.8
Primary outcomeMean· From baseline to end of Treatment (10 weeks)

Change in Post Traumatic Stress Disorder Symptom Severity - Self Report

GroupValue (units on a scale)Spread
Oxytocin-19.418
Placebo-25.218

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
OxytocinA 40-International Unit (IU) dose of intranasal oxytocin self-administered 30 minutes prior to the start of each weekly Prolonged Exposure therapy session. All participants assigned to 10 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.0 / 921 / 9228 / 92
PlaceboAn identical intranasal placebo dose was self-administered 30 minutes prior to the start of each weekly Prolonged Exposure therapy session. All participants assigned to 10 weekly, 90-minute therapy sessions delivered by trained Masters or Doctoral-level clinicians consistent with the published manual.0 / 880 / 8823 / 88

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Clinical trial · 2020

Enhancing prolonged exposure therapy for PTSD among veterans with oxytocin: Design of a multisite randomized controlled trial.

Flanagan et al. 2020Contemporary clinical trialscited by 6

PMID 32561468PMC7484278DOI 10.1016/j.cct.2020.106074PUB-32561468

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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