Oxytocin and Affect Processing in Posttraumatic Stress Disorder

What Was Tested

This registered phase 2 trial tested Oxytocin.

The investigators will use multiple methods (including Oxytocin intranasal inhalation, neuroimaging, behavioral measures, peripheral hormone measurements) to examine how individuals' behavior, cognition, and brain function is impacted by the neuro-hormone Oxytocin.

Specifically, the investigators plan to evaluate the influence of Oxytocin administration on affective processing in non-trauma exposed and trauma-exposed adults (both with and without posttraumatic stress disorder, PTSD).

It had three arms (groups): Healthy adult controls (18-55) (experimental), Adults with PTSD (18-55) (experimental) and Trauma-exposed/no-PTSD adults (18-55) (experimental).

The registry classes the interventions as drug.

More on the Plan

The investigators expect oxytocin (compared to placebo) to positively influence affect processing in healthy subjects, as well as among those diagnosed with PTSD.

The investigators expect oxytocin to impact participants' brain function as measured with functional magnetic resonance imaging (fMRI) while visually processing social and affect-related stimuli, rendering brain function and affective processing to be "more typical" or "adaptive" compared to placebo.

Oxytocin's effect on human repertoire is not necessarily direct, but can interact with the individual's socioemotional characteristics, early life environment, and psychiatric symptoms.

Therefore, the investigators will incorporate measures that capture the various dimensions that likely shape the effect of oxytocin.

Who Took Part

The registry lists 11 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Adults: age 18-55. Be in good medical health. Be cooperative with testing. English is a language spoken in the family. PTSD as diagnosed by a certified clinician or the research team for PTSD group.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: moderate or severe acute or chronic medical illnesses (e.g.cardiac disease, diabetes, epilepsy, influenza); history of hypertension with baseline blood pressure above 160 mm hg (systolic) over 100 mm hg (diastolic); history of syncope and/or baseline blood pressure below 100 mm hg (systolic).

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Oxytocin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-08 with completion listed for 2016-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): fMRI Analysis: Change in Anterior Insula Region (time frame: 1 week; fMRI data collected at second and third visits, one week apart). fMRI Analysis: Change in Accumbens Region (time frame: 1 week; fMRI data collected at second and third visits, one week apart). fMRI Analysis: Change in Amygdala Region (time frame: 1 week; fMRI data collected at second and third visits, one week apart).

It also tracked 1 secondary outcome, for example Salivary Oxytocin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 11 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.