Search / Trial NCT00001481

The Role of Hormones in Postpartum Mood Disorders

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

Trial Information

Current as of June 14, 2024

Recruiting

Keywords

Postpartum Disorders Mood Hormones Gn Rh Agonist Postpartum Depression

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 hormo...

Gender

Female

Eligibility criteria

  • INCLUSION CRITERIA:
  • A. 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.
  • B. 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.
  • C. 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.

Attachments

readout_NCT00001481_2024-06-14.pdf

4.5 MB

NCT00001481_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

ongoing

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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