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Home > "T" Clinical Trials Conditions > The Effects of Hormones in Postpartum Mood Disorders  The Effects of Hormones in Postpartum Mood Disorders
The Effects of Hormones in Postpartum Mood Disorders
For Condition: Depressive Disorder,Mood Disorder,Postpartum Depression
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to determine how women who have experienced a postpartum mood disorder respond to estrogen and progesterone in comparison to women who have had an episode of major depression not related to PPD, and in comparison with women who have not experienced mood disorders. Mood and behavioral disturbances during pregnancy and following delivery affect a large group of women, yet the causes of postpartum disorder (PPD) remain undetermined. Previous studies suggest that women with menstrual cycle-related mood disorders experience mood disturbances when the gonadal hormones estrogen and progesterone are replaced. This study will determine whether the abrupt withdrawal of, or prolonged exposure to, gonadal hormones is associated with mood disturbances. This study will use the drug leuprolide acetate to simulate a hormonal state of pregnancy and the 6-week period following delivery in both women who have experienced a postpartum mood disorder and those who have not. Participants will be given leuprolide acetate at the beginning of the study. Participants will then receive estradiol and progesterone for 8 weeks. After 8 weeks, administration of estradiol and progesterone will be stopped in one group of participants; the other group will continue taking estrogen and progesterone for an additional month. Mood symptoms and hormone levels will be measured throughout the study.
Details: 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).
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: The subjects of this study will be women who meet the following criteria: A history of DSM-IV major depression or hypomanic/manic episode that occurred within three months of childbirth; Has been well for a minimum of one year; A regular menstrual cycle for at least three months; Age 18-40; Not be pregnant, not lactating and in good medical health; Medication free, including birth control pills; No history of suicide attempts or psychotic episodes requiring hospitalization. EXCLUSION CRITERIA: Any women with a current axis I psychiatric diagnosis. Women with specific medical conditions or histories will also be excluded.
Total Enrollment: 80
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Linda Clair 3014969576
Additional Information:
Study ID Numbers: 950097; 95-M-0097
Study Start Date: March 31, 1995
Record last reviewed: April 15, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001481
Other Depressive Disorder Studies:
1. Psychosocial Correlates and Coping Strategies Associated with Long-Term Survival of HIV-Infected Children
2. Consequences of Conjugal Bereavement in Adults
3. Clinical Trial of Leuprolide Acetate for the Treatment of PMS
4. Progestin (progesterone-like hormones) induced dysphoria (depressed mood, irritability, anxiety)
5. Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Related Studies:
Other Depressive Disorder Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Effects of Hormones in Postpartum Mood Disorders
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