Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study

What Was Tested

This registered phase 2, phase 3 trial tested Oxytocin.

This research study will look at brain and symptom differences among women with severe premenstrual mood symptoms.

One goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on brain areas involved in emotion regulation while viewing pictures during a neuroimaging (fMRI) session.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 actual participants took part.

It was open to women only aged from 18 years up to 52 years.

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

Examples of who could join: In order to be eligible to enter this study, subjects will have met PMDD Study Entry Criteria in the diagnostic feeder study (IRB# 05-3000). 18 to 52 years of age. Regular menstrual cycles. Ability to give informed consent.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: current psychiatric diagnosis of substance abuse or claustrophobia (fear of closed places); pregnancy (based on urine pregnancy test) or breastfeeding; use of psychiatric medication (e.g. for depression, anxiety), hormonal medication, other agents that alter mood or thinking, or street drugs.

How the Study Was Run

Design: randomized, crossover and single-blind.

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

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

Only one side, usually the participants, was kept unaware of whether Oxytocin was given.

Those kept unaware of assignments: participant.

It started in 2015-07 with completion listed for 2016-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Premenstrual Symptom Severity (time frame: During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)). Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) (time frame: 1 hour of scanning during the late luteal phase of two consecutive menstrual cycles).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Oxytocin in 10 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.