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NCT04051320 · ClinicalTrials.gov registry record · Phase 2
Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model
A Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT04051320: Completed Phase 2 study, sponsored by University of North Carolina, Chapel Hill.
NCT04051320 is a Phase 2 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04051320, a Phase 2 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritability in past studies, will be used to examine the neurocircuitry underlying irritability under baseline and hormone challenge conditions among women who are hormone sensitive (HS+; n=15) and non-hormone sensitive (HS-; n=15). The long-term goal of this research is to advance understanding of the neural systems underlying both the triggering of and susceptibility to irritability in women. The objective of the current project is to examine whether HS+ show differences in the behavioral activation system relative to HS- under baseline and hormone challenge conditions using functional magnetic resonance imaging (fMRI) and behavioral tests.
Primary Outcome
This outcome measure determines the extent to which irritability is characterized by dysfunctional threat processing during reproductive hormone challenge relative to baseline in HS+ and HS- by examining threat attention bias assessed during the visual dot-probe paradigm. The Visual Dot-Probe Paradigm asks participants to detect a target stimulus that is embedded in a matrix of distracting stimuli (e.g., a target stimulus, an angry face, might be embedded in a matrix of neutral distractor faces
Interventions
- DRUG Micronized progesterone
- DRUG Leuprolide Acetate 3.75 MG/ML
- DRUG Estradiol 2 Mg tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2020-01-02 |
| Est. Completion | 2022-07-19 |
| Phase | Phase 2 |
What the finished NCT04051320 record still lists
NCT04051320 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Micronized progesterone is the first listed.
NCT04051320 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04051320 about?
NCT04051320 is a clinical study titled "Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model". The proposed study involves experimentally manipulating reproductive hormones in nonpregnant, euthymic women to create a scaled down version of the changes that occur during pregnancy and the postpartum period. This endocrine manipulation paradigm, which the investigators have shown provokes irritab...
What is the current status of trial NCT04051320?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2020-01-02. Estimated completion is 2022-07-19.
What interventions are being tested in trial NCT04051320?
The interventions under investigation include: Micronized progesterone (DRUG), Leuprolide Acetate 3.75 MG/ML (DRUG), Estradiol 2 Mg tablet (DRUG).
Who is sponsoring clinical trial NCT04051320?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04051320's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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