MedTrace Logo

The Role of Hormones in Postpartum Mood Disorders

NCT00001481 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-12-05

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Peter J Schmidt, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-04-26
Primary Completion
2024-10-25
Completion
2024-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001481 on ClinicalTrials.gov