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


Study is Available At:


Original ID:

14-1153


NCT ID:

NCT02508103


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

Phase 2/Phase 3


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

52 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of North Carolina, Chapel Hill


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

13


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:July 2015
Completion Date:December 2017
Completion Type:Anticipated
Primary Completion Date:June 2016
Primary Completion Type:Actual
Verification Date:October 2016
Last Changed Date:October 26, 2016
First Received Date:July 22, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in premenstrual symptom severity
Time Frame:During the late luteal phase of two consecutive menstrual cycles (an average of 3-5 days of treatmen
Safety Issues:False
Description: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.

Study Interventions

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

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Intranasal placebo spray (3x/day) for 4-5 days
Study Arm Type:Experimental
Arm Name:Oxytocin
Description:Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of North Carolina, Chapel Hill

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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