CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
Oxytocin +1 moredrug
Likely dose
Oxytocin 40 IUfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02508103
NCT02508103Phase 3Completed
CompareCT.gov

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

University of North Carolina, Chapel Hill·interventional·Posted Jul 24, 2015·Updated Jun 27, 2017

In Brief

A Phase 3 clinical trial evaluating Oxytocin and Placebo for Premenstrual Dysphoric Disorder. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPremenstrual Dysphoric Disorder
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 24, 2015
Enrollment StartJul 1, 2015
Primary CompletionJun 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.9 years ago

Interventions

Oxytocindrug

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

Placebodrug

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