Prolonged Exposure and Oxytocin

What Was Tested

This registered phase 2 trial tested Oxytocin.

Posttraumatic stress disorder (PTSD) is a chronic, debilitating anxiety disorder that may develop after direct or indirect exposure to traumatic events.

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

Placebo is matching saline nasal spray.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 17 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female; any race or ethnicity; age 18-75 years. Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments. Participants must be able to comprehend English. Meet DSM-5 criteria for current PTSD (assessed via the Clinician Administered PTSD Scale; CAPS). A CAPS score of 50 or greater.

The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 8 weeks; participants meeting dsm-5 criteria for a substance use disorder, except caffeine or nicotine, within the past 12 months; pregnant women will be excluded from the proposed study.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

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 2015-01-01 with completion listed for 2016-12-31.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): PTSD Symptom Severity (time frame: Change from Baseline to end of treatment (10 weeks)).

It also tracked 2 secondary outcomes, for example PTSD Symptom Severity and Depression Symptom Severity.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 17 people.

Its size is small, so on its own it can only give an early look.

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.