At a glance
ClinicalIndex Comparison Record- ✓Group 1: History of DSM-IV major depression or hypomanic/manic episode within 3 months of childbirth (confirmed by SCID interview)
- ✓Group 2: History of DSM-IV major depression episode(s) outside of pregnancy and not within 3 months postpartum
- ✓Group 3: Normal controls with no past or present Axis I diagnosis or menstrual-related mood disorders
- ✓Well/stable for minimum of 1 year
- ✕History of suicide attempts or psychotic episodes requiring hospitalization
- ✕Endometriosis
- ✕Undiagnosed enlargement of the ovaries
- ✕Liver disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Endocrine Model for Postpartum Mood Disorders
In Brief
A Phase 2 clinical trial evaluating Estradiol, Placebo, and 2 other interventions for Postpartum Depression. Completed, enrolled 74 participants across 1 site.
Detailed Summary
The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms.
Study Details
Timeline
Interventions
Participants receive 17 beta-estradiol as oral capsule twice daily
Participants receive placebo as oral capsule twice daily
Participants receive progesterone as oral capsule twice daily
Leuprolide acetate is a gonadotropin releasing hormone (GnRH) agonist, given via intramuscular injection monthly