Neurophysiology of Postpartum Depression in an Experimental Model of Pregnancy and Parturition

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.

Conditions

• Postpartum Depression

Interventions

DRUG

Leuprolide Acetate

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

DRUG

Micronized estradiol

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.

DRUG

Progesterone

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.

Sponsors & Collaborators

• Foundation of Hope, North Carolina

  collaborator OTHER

• North Carolina Translational and Clinical Sciences Institute

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Alliance for Research on Schizophrenia and Depression

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of North Carolina, Chapel Hill

  lead OTHER

Principal Investigators

• Crystal E Schiller, Ph.D. · University of North Carolina, Chapel Hill

• David R Rubinow, M.D. · University of North Carolina, Chapel Hill

Study Design

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2016-10-13

Completion

2016-10-13

Countries

• United States

Study Locations