Oxytocin to Treat PTSD

What Was Tested

The trial (phase 2) is built around Oxytocin.

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition that disproportionately affects Veterans.

Prolonged Exposure (PE) therapy is a "gold standard" treatment for PTSD.

It had two arms (groups): Oxytocin (experimental) and Placebo (placebo comparator).

Intranasal saline spray.

The registry classes the interventions as drug and other.

More on the Plan

For example, approximately one-third of patients dropout of PE treatment prematurely, and the highest dropout rates occur among Veterans.

Furthermore, recent neuroimaging studies show that oxytocin has the ability to ameliorate dysregulation of the corticolimbic brain circuitry, which is a central component of the pathophysiology and maintenance of PTSD.

To accomplish these objectives, the investigators will employ a randomized, double-blind, placebo-controlled trial and use standardized, repeated dependent measures of change at five time points (baseline, mid-treatment, end of treatment, and 3 and 6 month follow-up).

Who Took Part

180 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: anxiety disorders (e.g. panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder); 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-01-01 with completion listed for 2025-02-28.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Post Traumatic Stress Disorder Symptom Severity - Clinician Rated (time frame: From baseline to of Treatment (10 weeks)). Change in Post Traumatic Stress Disorder Symptom Severity - Self Report (time frame: From baseline to end of Treatment (10 weeks)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 180 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Oxytocin compound page, all human trials.