Phase 3
N=10
Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
Premenstrual Dysphoric Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02508103 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Change in Premenstrual Symptom Severity — 25.05; 27.36 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Oxytocin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Premenstrual Symptom Severity |
25.05; 27.36 | — |
| PRIMARY Amygdala Response to Cognitive-emotional Processing Task During Functional Magnetic Resonance Imaging (fMRI) |
0.89; 0.95; 1.14; 1.22 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02508103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.