The Role of Hormones in Postpartum Mood Disorders

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

Keywords

ClinConnect Summary

This clinical trial is studying the potential link between hormone changes and postpartum depression (PPD). Researchers want to find out if stopping hormones like estrogen and progesterone suddenly after childbirth could trigger mood problems in women who have experienced PPD before. To do this, they will give certain women these hormones for a set period and then rapidly stop them in some participants, while others will continue to receive them for a longer time. The goal is to see how these changes affect mood and behavior.

Women aged 18 to 50 who have a history of postpartum depression or major depressive disorder may be eligible to participate. To qualify, participants must have been well for at least a year, have a regular menstrual cycle, and not be pregnant or breastfeeding. They should also be in good health and not currently taking any medications. If you or someone you know is interested, participants can expect to be closely monitored for mood changes and hormonal levels throughout the study. It's important to note that there are specific health exclusions, so a thorough health assessment will be conducted before participation.

Gender

FEMALE

Eligibility 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 18-50;
• • 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 three months postpartum;
• • 2. has been well for a minimum of one year;
• • 3. a regular menstrual cycle for at least three months;
• • 4. age 18-50;
• • 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.
• • C. Group 3: Normal Controls
• • 1. 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.

Trial Officials