Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001481
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
1999-11-03
Brief Title:
The Role of Hormones in Postpartum Mood Disorders
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
An Endocrine Model for Postpartum Mood Disorders
Status:
RECRUITING
Status Verified Date:
2024-06-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 a separate protocol done in collaboration with NICHD
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 a separate protocol done in collaboration with NICHD
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 estradiol and progesterone for an additional month Outcome measures will include mood behavioral and hormonal parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-M-0097 | None | None | None |