CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Leuprolide Acetate +2 moredrug
Likely dose
Leuprolide Acetate 3.75 mgfrom 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/NCT01762943
NCT01762943N/ACompleted
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Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition

University of North Carolina, Chapel Hill·interventional·Posted Jan 8, 2013·Updated Nov 20, 2017

In Brief

A clinical study evaluating Leuprolide Acetate, Micronized estradiol, and 1 other intervention for Postpartum Depression. Completed, enrolled 36 participants across 1 site.

Detailed Summary

Understanding the neural and biological mechanisms by which reproductive hormones influence mood is critically important for public health given that postpartum depression (PPD) is the leading cause of morbidity and mortality associated with childbirth and has negative effects on infants. Using a hormone-withdrawal challenge to precipitate mood symptoms will improve our ability to identify the biological mechanisms underlying both the triggering of and susceptibility to depressive disorders in women; and will permit the prediction of those at risk for PPD and other reproductive-related mood disorders.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostpartum Depression
CountriesUnited States
CollaboratorsFoundation of Hope, North Carolina, North Carolina Translational and Clinical Sciences Institute, National Institutes of Health (NIH), National Alliance for Research on Schizophrenia and Depression, National Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2013
Enrollment StartAug 1, 2013
Primary CompletionOct 13, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.5 years ago

Interventions

Leuprolide Acetatedrug

All subjects will receive one IM injection (3.75 mg) each month for four months.

Micronized estradioldrug

All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.

Progesteronedrug

All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.