Intranasal Oxytocin (40 IU) Investigated for Neurophysiological and Symptomatic Effects in Premenstrual Mood Disorders

Treating mood disorders, particularly severe premenstrual mood symptoms, presents a significant challenge, with a pressing need for innovative therapeutics. Current standard-of-care options often fall short in terms of efficacy, time-to-peak effect, and durability. There's a strategic imperative to identify novel mechanisms that translate into improved treatments. This study aims to explore neurophysiological, endocrinological, cognitive, and psycho-social-emotional markers to identify new targets for integrative health treatments, specifically focusing on the potential of oxytocin to address these gaps.

This multi-modal study is recruiting women with severe premenstrual mood symptoms from a university-based mood disorders program. Participants are enrolled in a randomized, placebo-controlled design. The intervention involves administering Intranasal Oxytocin spray at a dose of 40 IU, three times daily (3x/day), for a duration of 4-5 days. The control arm receives an Intranasal Placebo spray, also 3x/day for 4-5 days. The study aims to investigate various markers, including neurophysiological, endocrinological, cognitive, and psycho-social-emotional indicators of disease, to assess the effects of the intervention.

This document outlines the protocol for a multi-modal study, not its completed findings. Data analysis is scheduled from January 7, 2025, through February 3, 2025, indicating that results are not yet available. Therefore, no specific neurophysiological, endocrinological, cognitive, or psycho-social-emotional markers or their changes in response to intranasal oxytocin can be reported at this time. The study aims to identify such markers and evaluate the effects of the intervention, but the outcomes are pending completion of the trial and subsequent analysis. No statistical data, p-values, or fold-changes are presented in this protocol description.