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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)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I am mentally capable of understanding and participating in the trial.

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I have been diagnosed with an anxiety disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of treatment (10 weeks)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Number of homework assignments completed

Number of sessions attended

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,305,096 Total Patients Enrolled

San Francisco VA Health Care SystemFED

9 Previous Clinical Trials

864,773 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room in this experiment for additional participants?

"Affirmative. Clinicaltrials.gov has data which confirms that this medical study, initially posted on November 16th 2020, is actively looking for participants to enrol in the trial. A total of 188 patients must be recruited from two separate clinical centres."

Answered by AI

Does Oxytocin present any long-term risks for individuals?

"The safety of Oxytocin has been assessed at a 2 due to the current Phase 2 status, where there is evidence confirming its security but not yet any attesting to its efficacy."

Answered by AI

How many individuals are being enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov verifies that this medical trial is currently recruiting participants, with 188 needed from 2 sites since the listing was published on November 16th 2020 and last updated at the end of August 2022."

Answered by AI

Have prior experiments employed Oxytocin in their application?

"The initial investigation of oxytocin was conducted in 2011 at Hadassah University Medical Organization. As of today, 18536 studies have been finalized and 53 are presently underway; a significant amount of these experiments are being performed out of San Francisco, California."

Answered by AI

What therapeutic applications is Oxytocin typically utilized for?

"Oxytocin is regularly used to treat hemorrhage and can also be effective in the management of labour, uterine contraction, and facilitating childbirth."

Answered by AI