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The Role of Hormones in Postpartum Mood Disorders
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), April 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001481
  Purpose

Determine whether postpartum depression is triggered by the abrupt withdrawal of estrogen and progesterone.

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. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. 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 effective episode will experience differential mood and behavioral effects 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. Outcome measures will include mood, behavioral and hormonal parameters as well as response to o-CRH (a separate protocol done in collaboration with NICHD).

...


Condition
Depressive Disorder
Mood Disorder
Postpartum Depression
Depression

MedlinePlus related topics: Depression Postpartum Depression
Drug Information available for: Progesterone Gonadorelin Gonadorelin hydrochloride LH-RH
U.S. FDA Resources
Study Type: Observational
Official Title: An Endocrine Model For Postpartum Mood Disorders

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 80
Study Start Date: March 1995
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. Preliminary results from two related studies (protocols 90-M-0088, 92-M-0174) provide evidence that women with menstrual cycle related mood disorder, but not controls, experience mood disturbances during exogenous replacement of physiologic levels of gonadal steroids. 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 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. Outcome measures will include mood, behavioral and hormonal parameters as well as response to o-CRH.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

A. Group 1: Women with a history of postpartum depression:

  1. A history of DSM-IV major depression or hypomanic/manic episode that occurred within three months of childbirth (as determined by a SCID interview);
  2. has been well for a minimum of one year;
  3. a regular menstrual cycle for at least three months;
  4. age 18-40;
  5. not pregnant, not lactating and in good medical health;
  6. medication free (including birth control pills);
  7. no history of puerperal suicide attempts or psychotic episodes requiring hospitalization.

B. Group 2: Women with a history of Major Depressive Disorder

  1. A history of DSM-IV major depression episode(s) occurring outside of pregnancy and not within 3 months postpartum;
  2. has been well for a minimum of one year;
  3. a regular menstrual cycle for at least three months;
  4. age 18-40;
  5. not pregnant, not lactating and in good medical health;
  6. medication free (including birth control pills);
  7. no history of suicide attempts or psychotic episodes requiring hospitalization.

Normal Controls:

Controls will meet all criteria specified except they must not have any past or present Axis I diagnosis or evidence of menstrually related mood disorders.

EXCLUSION CRITERIA:

Any women with a current axis I psychiatric diagnosis.

Women with specific medical conditions or histories will also be excluded.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001481

Contacts
Contact: Linda Simpson-St. Clair, R.N. (301) 496-9576 simpsonl@irp.nimh.nih.gov
Contact: Pedro E. Martinez, M.D. (301) 496-5831 martinez@codon.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 950097, 95-M-0097
Study First Received: November 3, 1999
Last Updated: July 18, 2008
ClinicalTrials.gov Identifier: NCT00001481  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Postpartum Disorders
Depression
Mood
Postpartum Depression
Hormones
Pregnancy
Estrogen
Progesterone
Gonadal Steroids
GnRH Agonist
Postpartum Depression
Depression
Postpartum
Mood Disorder

Study placed in the following topic categories:
Deslorelin
Pregnancy Complications
Depression
Progesterone
Puerperal Disorders
Depression, Postpartum
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009