The Role of Hormones in Postpartum Mood Disorders

  • STATUS
    Recruiting
  • End date
    Jun 13, 2022
  • participants needed
    100
  • sponsor
    National Institute of Mental Health (NIMH)
Updated on 27 December 2020
Investigator
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Primary Contact
National Institutes of Health Clinical Center, 9000 Rockville Pike (9.7 mi away) Contact
gonadotropin
depression
estrogen
progesterone
psychosis
depressive disorder
mood symptoms
scid
depressed mood
suicide
mania
mood disorder
mood disturbances
postpartum depression
axis i diagnosis

Summary

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).

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 estradiol and progesterone for an additional month. Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH.

Details
Treatment Placebo, Estradiol, Progesterone
Clinical Study IdentifierNCT00001481
SponsorNational Institute of Mental Health (NIMH)
Last Modified on27 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 50 yrs?
Are you female?
Do you have any of these conditions: Affective Disorders or mood disorder or Depression (Adolescent) or Depression (Treatment-Resistant) or Endogenous depression or Depression (Pediatric)...?
Do you have any of these conditions: Depression or Endogenous depression or Affective Disorders or Depression (Pediatric) or Postpartum depression or Depression (Adult and Geriatric) or P...?
Do you have any of these conditions: mood disorder or Depression (Adolescent) or Depression (Treatment-Resistant) or Post-Partum Depression or Depression or Depression (Pediatric) or Depr...?
Do you have any of these conditions: Mood Disorders or Postpartum depression or Affective Disorders or Depression (Adult and Geriatric) or Depression (Pediatric) or Depression (Treatment-...?
Do you have any of these conditions: Depression or Affective Disorders or Mood Disorders (Pediatric) or Mood Disorders or Depression (Pediatric) or mood disorder or Endogenous depression ...?
Do you have any of these conditions: Depression (Major/Severe) or Postpartum depression or Depression (Adolescent) or Depression (Pediatric) or mood disorder or Mood Disorders (Pediatric)...?
Do you have any of these conditions: Affective Disorders or mood disorder or Endogenous depression or Depression (Pediatric) or Mood Disorders or Depression or Postpartum depression or Mo...?
Group 1: Women with a history of postpartum depression
A history of DSM-IV major depression or hypomanic/manic episode that occurred within three months of childbirth (as determined by a SCID interview)
has been well for a minimum of one year
a regular menstrual cycle for at least three months
age 18-50
not pregnant, not lactating and in good medical health
medication free (including birth control pills)
no history of puerperal suicide attempts or psychotic episodes requiring hospitalization
Group 2: Women with a history of Major Depressive Disorder
A history of DSM-IV major depression episode(s) occurring outside of pregnancy and not within three months postpartum
has been well for a minimum of one year
a regular menstrual cycle for at least three months
age 18-50
not pregnant, not lactating and in good medical health
medication free (including birth control pills)
no history of suicide attempts or psychotic episodes requiring hospitalization
Group 3; 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

Patients will not be permitted to enter this protocol if they have important
clinical or laboratory abnormalities including any history of the following
endometriosis
undiagnosed enlargement of the ovaries
liver disease
breast cancer
a history of blood clots in the legs or lungs
undiagnosed vaginal bleeding
porphyria
diabetes mellitus
malignant melanoma
gallbladder or pancreatic disease
heart or kidney disease
cerebrovascular disease (stroke)
cigarette smoking
a history of suicide attempts or psychotic episodes requiring hospitalization
recurrent migraine headaches
pregnancy (patients will be warned not to become pregnant during the study and
will be advised to employ barrier contraceptive methods
pregnancy-related medical conditions such as hyperemesis gravidarum
pretoxemia and toxemia, deep vein thrombosis (DVT) and bleeding diathesis
Any woman with a first degree relative (immediate family) with premenopausal
breast cancer or breast cancer presenting in both breasts or any woman who has
multiple family members (greater than three relatives) with postmenopausal
breast cancer will also be excluded from participating in this protocol
Any woman meeting the Stages of Reproductive Aging Workshop Criteria (STRAW)
for the perimenopause will be excluded from participation. Specifically, we
will exclude any woman with an elevated plasma FSH level (greater than or
equal to 14 IU/L) and with menstrual cycle variability of > 7 days different
from their normal cycle length
Subjects who are unable to provide informed consent
NIMH employees and staff and their immediate family members will be excluded
from the study per NIMH policy
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