Bipolar disorder (BP) is a serious psychiatric condition that affects 0.5 -1.5% of individuals in America. The age of onset of BP is during the initial childbearing years. Seventy percent of women with established BP will suffer recurrent episodes post-birth. Continuous medication administration is the mainstay of treatment for BP. Although the information available to physicians who treat pregnant women with unipolar depression has increased over the past decade, data to inform decisions about treatment of BP has not advanced similarly. Information about anticonvulsant use during pregnancy has been garnered solely from the study of women with epilepsy, who have increased risk for malformations independent of drug treatment. Data about atypical antipsychotic use in pregnancy is almost non-existent in either women with BP or schizophrenia. The majority of studies have not included the range of outcome measures that comprise the contemporary portfolio of the reproductive toxicity outcomes. Pharmacologists have produced data for altered physiologic states (renal or hepatic disease) and for other patient subpopulations (children and elderly). The need for similar studies in pregnancy is certainly no less than for these populations. New information must be obtained to guide risk-benefit decision-making to a new level of sophistication. This is a prospective observational study of women with BP during pregnancy and the mother-infant pairs n the first postpartum year. We plan to enroll 200 women with BP and 58 women without BP (for 140 and 40 completers, respectively). Decisions about treatment during pregnancy will be made by the woman with her physician (not associated with the study) prior to study enrollment. The major aims of the study are to define a cohort of pregnant women with DSM-IV defined BP and to: 1) Characterize the BP illness course in the population through pregnancy and the first postpartum year, with careful documentation of treatment(s) and gestational timing. 2) Evaluate function in the maternal role as well as occupational, educational and social domains. 3) Define pregnancy and infant outcomes in both medicated and unmedicated women with BP and compare them to those of unmedicated women without BP. Separation of the effects of medication from the disorder is critical to advance risk assessment. 4) Assess the infants' development through the first year of life. 5) Perform serum levels at 20, 30, and 36 weeks gestation to allow level/dose ratio monitoring for women who take medications during childbearing. The mother-infant serum levels of women with BP who breastfeed their infants also will be assayed. 6) Conduct pharmacokinetic (PK) studies on the subset of women who take lithium, the most common drug used to manage BP during pregnancy in our Center, at 20- 24 weeks, 32-36 weeks, and 12-16 weeks after birth. No such PK data are currently available. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
1R01MH075921-01A1
Application #
7143406
Study Section
Adult Psychopathology and Disorders of Aging Study Section (APDA)
Program Officer
Hillefors, MI
Project Start
2006-09-01
Project End
2011-08-31
Budget Start
2006-09-01
Budget End
2007-08-31
Support Year
1
Fiscal Year
2006
Total Cost
$667,898
Indirect Cost
Name
University of Pittsburgh
Department
Psychiatry
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Pinheiro, Emily A; Wisner, Katherine L; Clark, Crystal T (2018) Quetiapine Dose Adjustments in Pregnant and Postpartum Women With Bipolar Disorder. J Clin Psychopharmacol 38:89-91
Di Florio, A; Putnam, K; Altemus, M et al. (2017) The impact of education, country, race and ethnicity on the self-report of postpartum depression using the Edinburgh Postnatal Depression Scale. Psychol Med 47:787-799
Putnam, Karen T; Wilcox, Marsha; Robertson-Blackmore, Emma et al. (2017) Clinical phenotypes of perinatal depression and time of symptom onset: analysis of data from an international consortium. Lancet Psychiatry 4:477-485
Eckhardt, Cara L; Eng, Heather; Dills, John L et al. (2016) The prevalence of rapid weight gain in infancy differs by the growth reference and age interval used for evaluation. Ann Hum Biol 43:85-90
Kim, Deborah R; Pinheiro, Emily; Luther, James F et al. (2016) Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res 73:79-85
Logsdon, M Cynthia; Mittelberg, Meghan; Jacob, Alexandra E et al. (2015) Maternal-Infant interaction in women with unipoloar and bipolar depression. Appl Nurs Res 28:381-3
Postpartum Depression: Action Towards Causes and Treatment (PACT) Consortium (2015) Heterogeneity of postpartum depression: a latent class analysis. Lancet Psychiatry 2:59-67
Sit, Dorothy; Luther, James; Dills, John Louis Jesse et al. (2014) Abnormal screening for gestational diabetes, maternal mood disorder, and preterm birth. Bipolar Disord 16:308-17
Bogen, D L; Perel, J M; Helsel, J C et al. (2013) Pharmacologic evidence to support clinical decision making for peripartum methadone treatment. Psychopharmacology (Berl) 225:441-51
Thurston, Rebecca C; Luther, James F; Wisniewski, Stephen R et al. (2013) Prospective evaluation of nighttime hot flashes during pregnancy and postpartum. Fertil Steril 100:1667-72

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