NCT00001481

The Role of Hormones in Postpartum Mood Disorders

An Endocrine Model for Postpartum Mood Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: National Institute of Mental Health (NIMH) · NIH
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The appearance of mood and behavioral symptoms during pregnancy and the postpartum period has been extensively reported. While there has been much speculation about possible biologically based etiologies for postpartum disorders (PPD), none has ever been confirmed. The present protocol is designed to create a "scaled-down" hormonal milieu of pregnancy and the puerperium in order to determine whether women who have had a previous episode of postpartum major affective episode will experience differential mood and behavioral effects during ovarian hormone exposure and/or withdrawal compared with controls and to determine whether it is the abrupt withdrawal of gonadal steroids or the prolonged exposure to gonadal steroids that is associated with mood symptoms. Supraphysiologic plasma levels of gonadal steroids will be established, maintained, and then rapidly reduced, simulating the hormonal events that occur during pregnancy and parturition. This will be accomplished by administering estradiol and progesterone to women who are pretreated with a gonadotropin releasing hormone (GnRH) agonist (Lupron). After eight weeks, administration of gonadal steroids will be stopped in one group of patients and controls, and a sudden decline in the plasma hormone levels will be precipitated. Another group will be maintained on supraphysiologic levels of estrogen and progesterone for an additional month.

Conditions

• Postpartum Depression

Interventions

Type	Name	Description
DRUG	Estradiol	Participants receive 17 beta-estradiol as oral capsule twice daily
OTHER	Placebo	Participants receive placebo as oral capsule twice daily
DRUG	Progesterone	Participants receive progesterone as oral capsule twice daily
DRUG	leuprolide acetate	Leuprolide acetate is a gonadotropin releasing hormone (GnRH) agonist, given via intramuscular injection monthly

Timeline

• Start date: 1996-04-26
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 1999-11-04
• Last updated: 2025-12-05
• Results posted: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study