Bipolar Disorder (BPD) in Pregnancy: Predictors of Morbidity
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Women's Studies, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/11/2012 |
| Start Date: | May 2005 |
| End Date: | July 2010 |
| Contact: | Bettina T Knight, BSN, RN CCRC |
| Email: | bknight@emory.edu |
| Phone: | 404-778-2496 |
Bipolar Disorder in Pregnancy: Predictors of Morbidity
Very little is known about the impact of pregnancy and the postpartum period on BPD. As a
result, the investigators have little evidence on which to base treatment guidelines. The
main goal of this study is to help fill this gap by finding the risk factors for BPD relapse
during pregnancy and the postpartum period.
The risk factors that the investigators will study include:
1. the severity of illness in the past
2. the type and severity of both recent and past stressors
3. any treatments received during pregnancy and the postpartum period.
Other goals of the study are:
1. to see what effect, if any, illness or any medicines taken during pregnancy have on the
baby's well-being at delivery
2. to see how pregnancy alters the way the body clears any medicines taken for BPD
3. to see how much of these medicines babies are exposed to during pregnancy or
breast-feeding.
The investigators believe that the information gathered in this study will lead to new
treatment guidelines for BPD during pregnancy and the postpartum period that will improve
outcomes for pregnant women with BPD and their babies.
Despite the significant morbidity of bipolar disorder (BPD) and its high prevalence during
the childbearing years, remarkably little is known about the impact of the female
reproductive life cycle on BPD. Clinicians lack evidence-based guidelines for the perinatal
management of BPD. The proposal addresses an understudied area with considerable public
health implications for the estimated 100,000 women with BPD who conceive each year in the
US.
The broad goal of this project is to delineate the clinical, psychosocial, and in
particular, pharmacologic predictors of BPD recurrence during pregnancy. Preliminary
findings suggest that inadequate treatment is a particularly robust predictor of prenatal
BPD recurrence. Consequently, a specific emphasis will be placed on investigating the
recurrence risk associated with suboptimal pharmacotherapy occurring as a result of
medication discontinuation or declining drug concentrations secondary to increased prenatal
clearance.
A prospective cohort design with monthly assessments will be implemented in a collaborative
investigation between two of the leading perinatal psychiatry academic centers in the US
with specific expertise in mood disorders research during pregnancy. The specific aims are
1) to quantify the risks for both syndromal and subsyndromal prenatal BPD illness associated
with suboptimal pharmacotherapy while controlling for the severity of the previous course of
illness and recent psychosocial stressors, 2) to examine the association of maternal
prenatal BPD morbidity and psychotropic exposure with infant outcome at delivery thereby
filling a current void and rounding out the requisite facets of the clinical risk/benefit
assessment, and 3) to conduct pharmacokinetic (PK) modeling in an effort to delineate
pregnancy-associated changes in drug clearance and provide initial reliable estimates of
fetal drug exposure.
Study results will represent an incremental advance that: 1) elucidates risk factors for BPD
morbidity during pregnancy; 2) contributes clinically relevant data to establish therapeutic
guidelines for BPD during pregnancy; and 3) serve as a basis for preventive strategies aimed
at optimizing maternal and infant outcome. Furthermore, the novel PK data will expand our
understanding of prenatal drug metabolism, and the project will establish a cohort of
children of women with BPD with detailed prospective prenatal histories.
Inclusion Criteria:
- Medically healthy adult women (ages 18-45) fulfilling DSM-IV criteria for BPD of any
subtype who are ≥ 16 weeks gestation dated by last menstrual period (LMP)
- Able to give informed consent and comply with study procedures
Exclusion Criteria:
- Actively suicidal or homicidal
- Active substance use disorder within 6 months prior to enrollment
- Positive urine drug screen
- Hematocrit < 30
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