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

Premenstrual Dysphoric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02508103
• Other study ID #: 14-1153
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: July 22, 2015
• Last updated: October 26, 2016
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: December 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Premenstrual Dysphoric Disorder

Intervention

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

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in premenstrual symptom severity	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.	During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatment)	No
Primary	Neural response to cognitive-emotional processing tasks during functional magnetic resonance imaging (fMRI)	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.	1 hour of scanning during the late luteal phase of two consecutive menstrual cycles	No