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Oxytocin for PTSD

Phase 2
Recruiting
Led By Julianne Christina Flanagan, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Anxiety disorders (e.g. panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (10 weeks)

Summary

This trial will examine the ability of oxytocin to reduce PTSD symptoms, compared to placebo, when combined with Prolonged Exposure therapy. The study will be conducted with Veterans and has the potential to significantly improve mental health care among Veterans.

Who is the study for?
This trial is for Veterans with PTSD, who can consent and perform well on a mental status exam. They may have mood or anxiety disorders but not bipolar disorder or current severe suicidal thoughts. Stable psychotropic medication use is okay.
What is being tested?
The study tests if oxytocin can improve PTSD symptoms and treatment retention in Veterans undergoing Prolonged Exposure therapy, compared to a placebo. Participants can join sessions via telemedicine using VA approved apps.
What are the potential side effects?
While the trial description doesn't list specific side effects of oxytocin, common ones might include emotional changes, nausea, pain at injection site, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am mentally capable of understanding and participating in the trial.
Select...
I have been diagnosed with an anxiety disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (10 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of treatment (10 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PTSD Symptom Severity as measured by the PTSD Checklist (PCL-5)
PTSD symptom severity as measured by the Clinician-Administered PTSD Scale (CAPS-5)
Secondary study objectives
Number of homework assignments completed
Number of sessions attended

Side effects data

From 2023 Phase 4 trial • 108 Patients • NCT04028765
6%
Blood transfusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Misoprostol-Mothers
Oxytocin-Mothers
Oral Misoprostol-Fetus/Neonate
Oxytocin-Fetus/Neonate

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: OxytocinExperimental Treatment1 Intervention
40 IU intranasal oxytocin
Group II: PlaceboPlacebo Group1 Intervention
intranasal saline spray
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxytocin
2016
Completed Phase 4
~2340

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,537 Total Patients Enrolled
San Francisco VA Health Care SystemFED
10 Previous Clinical Trials
864,803 Total Patients Enrolled
Julianne Christina Flanagan, PhDPrincipal InvestigatorRalph H. Johnson VA Medical Center, Charleston, SC

Media Library

Oxytocin Clinical Trial Eligibility Overview. Trial Name: NCT04228289 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Oxytocin, Placebo
Post-Traumatic Stress Disorder Clinical Trial 2023: Oxytocin Highlights & Side Effects. Trial Name: NCT04228289 — Phase 2
Oxytocin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228289 — Phase 2
~11 spots leftby Feb 2025
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