The Efficacy of a Single Dose of Intranasal Oxytocin in the Prevention of Post Traumatic Stress Disorder (PTSD)

What Was Tested

This registered not phased trial tested Oxytocin.

In the absence of such treatment (i.e., under placebo conditions), the researchers hypothesize that a greater proportion of persons will develop PTSD (i.e., fail to recover from acute effects).

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

The registry classes the interventions as drug.

More on the Plan

After two weeks the research assistant or study psychiatrist will perform behavioral ratings and complete history details pertaining to PTSD risk factors.

Participants will be assessed again by the study psychiatrist or research assistants at 1, 3, 6 and 13 months.

Eligible subjects will include men and women over the age of 18, who have been exposed to an event meeting the DSM-IV "A.1" criterion for trauma exposure, and who provide written, informed consent to participate in the study.

In order to recruit persons who are more likely to be at risk for the development of PTSD, the researchers will only randomize persons expressing marked anxiety, emotional distress or dissociation, as assessed by the Visual Analog Scales.

Who Took Part

The registry lists 24 planned participants were the target.

It was open to people of any sex aged from 18 years up to 67 years.

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

Examples of who could join: The person can and is willing to provide written, informed consent to participate in the study.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: head injury involving confusion, loss of consciousness, or amnesia;; weight below 45 or above 100 kg; traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period.

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 2010-02 with completion listed for 2011-01.

It ran at 1 site in Israel.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: The primary outcome measure is DSM-IV diagnosis of PTSD at the end of the trial (time frame: 13 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 24 people.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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