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

NCT ID: NCT02508103

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Premenstrual Dysphoric Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Oxytocin, then Placebo

Participants were randomized to receive Intransal Oxytocin for late luteal phase administration during one menstrual cycle, then received Intranasal Placebo for late luteal phase administration of a subsequent menstrual cycle.

Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Placebo, then Oxytocin

Participants were randomized to receive Intranasal Placebo for late luteal phase administration during one menstrual cycle, then received Intransal Oxytocin for late luteal phase administration of a subsequent menstrual cycle.

Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days; Intranasal Placebo spray (3x/day) for 4-5 days

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

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

Interventions

Oxytocin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 52 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Susan Girdler, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Girdler, PH.D.

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

14-1153

Identifier Type: -

Identifier Source: org_study_id