Sex/Gender Differences in Risk and Resilience to PTSD; Implication of Oxytocin

What Was Tested

In this phase 2 trial, researchers set out to test Oxytocin.

The purpose of the study is to use fMRI to investigate amygdala response to fearful faces in men and women with and without PTSD who have experienced childhood trauma.

The study will also compare the effects of oxytocin and placebo on amygdala response, and explore the interaction of oxytocin plasma levels and amygdala response in men and women with and without PTSD who have experienced childhood trauma.

Hypothesis 1: Amygdala responding will be greater in subjects with PTSD as compared to resilient subjects, and no sex differences in the magnitude of the response will be found.

It had four arms (groups): PTSD placebo Day 1, Oxytocin Day 2 (placebo comparator), PTSD Oxytocin Day 1, Placebo Day 2 (experimental), Resilient Placebo Day 1, Oxytocin Day 2 (placebo comparator) and Resilient Oxytocin Day 1, Placebo Day 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 38 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Subjects scoring moderate to severe (\>3) on a minimum of one of the five trauma domains of the Childhood Trauma Questionnaire.

The full record lists 3 inclusion and 13 exclusion criteria; among the exclusions: subjects with evidence of or a history of head trauma, neurological disorders, seizures, unconsciousness or any other major medical disorder; subjects with current (past 90 days) psychotic disorder or bipolar affective disorder; subjects with any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

Each person switched between Oxytocin and the comparison at some point, usually with a gap in between.

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 and investigator.

It started in 2013-04 with completion listed for 2015-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in Amygdala Activation- Oxy Minus Placebo (time frame: Days 1 and 2).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 38 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.