The Effect of Intranasal Oxytocin on Emphatic Abilities in Patients With Post Traumatic Stress Disorder (PTSD)

What Was Tested

The trial (phase 4) is built around Oxytocin.

Oxytocin (OT) - a neurohormone and neuromodulator which is mainly synthesized in the hypothalamus - is a key mediator of complex social and affective behaviors, including emotional empathy.

According to these theories, dysfunction in the oxytocin system may modulate the interpersonal impairment that characterizes PTSD, and therefore intranasal OT may potentially relieve these symptoms.

It had two arms (groups): study group (experimental) and control group (other).

The registry classes the interventions as drug.

Who Took Part

62 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: PTSD patients (DSM-IV criteria). Ability to provide written informed consent.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: cardiac disease (arrythmia, heart failure); severe renal insufficiency; liver cirrhosis.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

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

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 2011-08 with completion listed for 2012-08.

It ran at 2 sites in Israel (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Computer tasks that assess empathy, Another goal of this study is to examine the relationship between empathic abilities and the ability to retrieve autobiographical memories among PTSD patients (time frame: 1 hour after the inhalation the OT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 62 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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