Lithium Therapy: Understanding Mothers, Metabolism and Mood
Status:
Active, not recruiting
Trial end date:
2020-06-01
Target enrollment:
Participant gender:
Summary
Lithium, the gold standard for treatment of Bipolar Disorder (BD) and a common augmentation
to medication therapy for Major Depression, is commonly continued in pregnancy due to its
therapeutic benefit and more recent data that suggests the teratogenic effects of lithium are
less than historically believed. Due to the increased elimination of lithium during
pregnancy, lithium concentration decreases in the blood and women with BD are vulnerable to
BD episode recurrence in pregnancy. Uncontrolled symptoms of BD in pregnancy increase the
risk for postpartum exacerbation of BD and psychosis. Our study will investigate the
pharmacokinetics (PK) of lithium prior to pregnancy, during pregnancy, and postpartum. Twenty
women taking lithium in pregnancy or planning to become pregnant and continue lithium will be
invited to participate in a study to measure repeated blood levels of lithium at six time
points between preconception and 3 months postpartum. The data collected will inform the
dose, timing of dose, and frequency of dosing of lithium that will lead to fewer untoward
effects for the mother and baby. Change in elimination clearance of lithium will be
correlated with symptom worsening to develop a dosing algorithm that will help maintain
wellness for pregnant women with mood disorders.