Expired Study
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Chapel Hill, North Carolina 27517


Purpose:

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.


Study 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.


Criteria:

Inclusion Criteria: - 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 Exclusion Criteria: - 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 - any foreign iron or steel metal objects in the body, such as a pacemaker, shrapnel, metal plate, certain types of tattoos, or metal debris


NCT ID:

NCT02508103


Primary Contact:

Principal Investigator
Susan Girdler, PH.D.
UNC-Chapel Hill


Backup Contact:

N/A


Location Contact:

Chapel Hill, North Carolina 27517
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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