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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: This research study will look at differences among women with severe premenstrual mood symptoms. One goal of this study is to look at how the brains of two groups of these women respond to emotional information. The two groups are women who were abused early in life and women who were not. The study will use a brain scan to look at how certain areas of the brain respond to the viewing of words and pictures. Another goal of this study is to look at the effects of taking a nasal spray containing oxytocin (a hormone made in the brain) on those same brain areas during the viewing of words and pictures. Also, the investigators will look at whether oxytocin given in the nose improves premenstrual mood symptoms.

Detailed Summary:

Purpose: The primary objective of this pilot study is to begin to identify the central networks using functional neuroimaging techniques that may contribute to the greater impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (PMDD) who also have a history of early life abuse (ELA).

Based on the evidence that the mammalian neuropeptide oxytocin (OT), best known for its role in lactation and parturition, plays a seminal role in social affiliation, emotion regulation, attachment, maternal behavior, trust, and protection against stress; and because OT neural pathways and receptors are prominently expressed in brain regions involved in emotion regulation and maternal/affiliative behavior; the study will: 1) use intranasal OT administration as a probe to assess whether it modifies activation of central regions involved in emotion regulation in response to cognitive emotional tasks; and 2) whether daily intranasal OT administration during the premenstrual phase improves symptoms in women with PMDD with or without a history of ELA.

Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• 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) ]
  The investigators will analyze premenstrual symptom severity ratings during the late luteal phase of two consecutive menstrual cycles to assess the effects of intranasal oxytocin (vs. placebo) on premenstrual symptom severity.
• Neural response to cognitive-emotional processing tasks during functional magnetic resonance imaging (fMRI) [ Time Frame: 1 hour of scanning during the late luteal phase of two consecutive menstrual cycles ]
  During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on neural response to cognitive-emotional processing tasks during the late luteal phase of two consecutive menstrual cycles.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: July 22, 2015
Date Started: July 2015
Date Completion: December 2017
Last Updated: October 26, 2016
Last Verified: October 2016