The Effect of Oxytocin Administration on Interpersonal Cooperation in Borderline Personality Disorder Patients and Healthy Adults

What Was Tested

The trial (not phased) is built around Oxytocin.

The study will examine behavioral patterns and underlying neural correlates which distinguish patients with borderline personality disorder (BPD) from healthy subjects as they participate in a two-person trust game and will determine whether administration of intranasal oxytocin (OT) will normalize trust game performance and concomitant neural processing in the BPD group.

It had two arms (groups): patients with BPD (other) and healthy patients (active comparator).

The registry classes the interventions as drug.

More on the Plan

This is a pilot study to support submission of a larger-scale federally funded study.

The study is designed to develop new strategies for treating the severe interpersonal dysfunction in borderline personality disorder (BPD) by modeling the interpersonal disturbance in BPD in the laboratory, identifying its neural correlates and determining whether the social neuropeptide, oxytocin, can ameliorate the interpersonal dysfunction.

Subjects are being recruited and may participate in the Trust Game task, but intranasal administration of oxytocin has temporarily been held because of the COVID-19 pandemic.

Who Took Part

Enrollment: 40 planned participants were the target.

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: BPD subjects meets criteria for DSM-IV Borderline Personality Disorder. 18 to 55 years old. All subjects will be free of psychotropic medications for 2 weeks (6 weeks for fluoxetine). Subjects may be enrolled in psychotherapy.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: substance abuse disorder in the prior 6 months; metallic foreign-bodies that contraindicate mri.

How the Study Was Run

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

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

In the crossover set-up each of the participants took both Oxytocin and the comparison in turn, acting as their own control.

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 2014-08-26 with completion listed for 2027-07.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Trust Game Affect Ratings (time frame: up to 4 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 40 people.

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

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