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Completed

NCT Number: NCT02508103

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

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. The investigators will also look at whether oxytocin improves premenstrual mood symptoms.

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Key information

Conditions

Premenstrual Dysphoric Disorder Depressive Disorder Menstruation Disturbances Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Premenstrual Syndrome

Age range

18 year–52 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27517, United States

About this study

Purpose: The primary objective of this pilot study is to use functional neuroimaging techniques to begin to identify the central brain networks that may contribute to impairment in emotion regulation, interpersonal relationships, and marital and family function in women with premenstrual dysphoric disorder (PMDD), particularly for those women 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 brain regions involved in emotion regulation in response to an emotional processing task; and 2) whether daily intranasal OT administration during the premenstrual phase improves symptoms in women with PMDD with or without a history of ELA.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxytocin

Drug

Intranasal Oxytocin spray (40 IU, 3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins

Placebo

Drug

Intranasal Placebo spray (3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins

Primary outcomes

  1. 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. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated "the degree to which the problems have been experienced today": 1-Not at all, 2-Minimal, 3-Mild, 4-Moderate, 5-Severe, or 6-Extreme. For each participant, we calculated a total score by summing all 24 items. We then calculated a mean total score for each condition by averaging all participants total scores in a given condition. Higher scores represent greater symptoms. Range of total score is 24 to 144.

  2. 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

    During fMRI scanning, the investigators will assess the effects of intranasal oxytocin (vs. placebo) on amygdala response to cognitive-emotional processing task (Hariri et al., 2006) during the late luteal phase of two consecutive menstrual cycles. Amygdala reactivity was assessed by extracting a "contrast of parameter estimate" (COPE) for each region (left and right amygdala). Regions were defined using binarized Harvard-Oxford Subcortical Atlas masks. The parameter estimate was the average estimate of all voxels in each region for the task contrast of viewing Faces vs. Shapes. We used neuroimaging software package FSL to calculate and extract these parameter estimates.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2015
Registry last updated
Jun 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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