Optimizing Medication Management for Mothers With Depression
Condition: Depression; Pregnancy
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      The purpose of this study is to explore the way the antidepressant concentration (amount of
      medication) in the blood changes due to the physiological changes in the body (i.e., changes
      in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of
      genetic factors on the degree of these changes. Changes in antidepressant concentration are
      important to monitor, as decreases in antidepressant concentration may lead to less than
      therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of
      depressive episodes. Increases in antidepressant concentration have the potential to lead to
      increased side effects. The study team is hoping to better understand the course of these
      changes across pregnancy and postpartum and how an individual's genetic makeup impacts these
      changes with the goal of developing guidelines to optimize antidepressant treatment of
      pregnant women.
    

Detailed description: 
      The overarching goal of this The Eunice Kennedy Shriver National Institute of Child Health
      and Human Development (NICHD) funded U54 Obstetric-Fetal Pharmacology Research Center study
      is to develop evidence to construct guidelines for the optimal use of selective serotonin
      reuptake inhibitor (SSRI) antidepressants in pregnant women. The progressive changes in
      plasma SSRI and metabolite concentrations across pregnancy and after birth will be determined
      in an observational study. Serial evaluations of depressive and anxiety symptoms and side
      effects will be obtained to evaluate their association with plasma concentrations at monthly
      intervals during pregnancy and twice post-birth. To assess the subjects' metabolic
      phenotypes, subjects have the option to receive a probe drug cocktail, which will be given to
      evaluate the activities of enzymes involved in antidepressant metabolism during the third
      trimester (when activity change is maximal) compared to the non-pregnant state after birth.

      Additionally, the study team will investigate the impact of genomic variability on
      inter-individual differences in SSRI dosing, plasma concentrations and pharmacodynamics
      during pregnancy, with a focus on genes involved in the metabolism and elimination of SSRIs,
      drug transporters responsible for SSRI access to the central nervous system, and genes
      encoding critical SSRI targets involved in therapeutic efficacy.

      Finally, the study team will determine the maternal-fetal plasma concentrations and
      pharmacogenetic characteristics associated with neonatal SSRI abstinence syndrome. Maternal
      and fetal genotypes will be assessed for their relationship to SSRI drug concentrations and
      neonatal abstinence syndrome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample of women taking sertraline (Zoloft), fluoxetine (Prozac), citalopram
        (Celexa), or escitalopram (Lexapro) in pregnancy and postpartum in areas surrounding
        Chicago, IL; Pittsburgh, PA and Galveston, TX.
      
Keywords: Pregnancy; Depression; Anxiety; Mental Health; Women