Effects of Oxytocin on Behavior and Physiology in a Psychotherapy Setting

What Was Tested

In this phase 4 trial, researchers set out to test Oxytocin.

Subjects-currently in outpatient mental health care--will participate in 2 psychotherapy sessions, one with oxytocin spray and one with placebo spray.

Sessions will be videotaped, and cortisol and heart rate will be measured.

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

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

Participant was randomized to receive placebo before the first psychotherapy session, and then received the active drug at the second visit.

The registry classes the interventions as drug.

Who Took Part

18 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: In current mental health treatment.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: diagnosis of schizophrenia or psychosis; diagnosis of autism or aspergers disorder; active substance use disorder.

How the Study Was Run

Design: randomized, crossover and triple-blind.

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, investigator and outcomes assessor.

It started in 2008-12 with completion listed for 2012-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Verbal and Nonverbal Behavior in Therapy Session: Effects of Drug (time frame: videotapes of session were reviewed and scored 1-3 months after the patient completes the study).

It also tracked 3 secondary outcomes, for example Salivary Cortisol, Heart Rate Variability (HRV) and Subjective Ratings of Anxiety and Trust of the Therapist.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Oxytocin in 18 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.