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NCT02508103 · ClinicalTrials.gov registry record · Phase 2
Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
A Phase 2 study of Premenstrual Dysphoric Disorder, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02508103: Completed Phase 2 study of Premenstrual Dysphoric Disorder, sponsored by University of North Carolina, Chapel Hill.
NCT02508103 is a Phase 2 study of Premenstrual Dysphoric Disorder that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02508103, a Phase 2 study of Premenstrual Dysphoric Disorder, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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. Daily premenstrual symptoms were measured using the Daily Record of Severity of Problems (DRSP; Endicott et al., 2006). Across 24 items representing emotional, physical, and behavioral symptoms, participants indicated "the degree to which the problems have been experienced
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Oxytocin
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT02508103 record still lists
NCT02508103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Premenstrual Dysphoric Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02508103 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02508103 about?
NCT02508103 is a clinical study titled "Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study". 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 pi...
What is the current status of trial NCT02508103?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-07. Estimated completion is 2016-07.
What conditions does trial NCT02508103 study?
This clinical trial studies the following conditions: Premenstrual Dysphoric Disorder.
What interventions are being tested in trial NCT02508103?
The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).
Who is sponsoring clinical trial NCT02508103?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02508103 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02508103's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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