CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Leuprolide Acetate 3.75 MG/ML +2 moredrug
Likely dose
Leuprolide Acetate 3.75 MG/MLfrom 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/NCT04051320
NCT04051320Phase 2Completed
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Characterizing the Neural Substrates of Irritability in Women: an Experimental Neuroendocrine Model

University of North Carolina, Chapel Hill·interventional·Posted Aug 9, 2019·Updated Aug 25, 2023

In Brief

A Phase 2 clinical trial evaluating Leuprolide Acetate 3.75 MG/ML, Estradiol 2 Mg tablet, and 1 other intervention for Perinatal Depression and 3 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPerinatal Depression, Post Partum Depression, Depression, Postpartum, Depression
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedAug 9, 2019
Enrollment StartJan 2, 2020
Primary CompletionJul 15, 2022
Study CompletionJul 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 6.9 years ago

Interventions

Leuprolide Acetate 3.75 MG/MLdrug

3.75 mg/month leuprolide acetate intramuscular injection

Estradiol 2 Mg tabletdrug

2 mg estradiol tablet

Micronized progesteronedrug

200 mg micronized progesterone tablets