Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The widespread and common use of quetiapine in childbearing and pregnant women demands more data to inform dosing and toxicity in pregnancy. The new FDA Pregnancy and Lactation Labeling Final Rule (PLLR) will go into effect on June 30th, 2015 and will replace the prior A, B, C, D, and X categories. Additionally, the PLLR will require information to aid prescribing decisions in three categories 1) Pregnancy (including labor and delivery), 2) Lactation, and 3) Females and Males of Reproductive Potential. The pregnancy category will include a subsection that will describe pharmacokinetic and pharmacodynamic characteristics of the medication in pregnancy, fetal risk, and data quality. The data collected in this study will update the FDA pregnancy pharmacokinetic section for quetiapine and inform physicians that prescribe to childbearing women.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Quetiapine Fumarate

Criteria

Inclusion Criteria:

• Age 18-45 years

• Pregnant, second trimester

• English-speaking

• DSM-V diagnosis of Bipolar Disorder or Schizophrenia, any subtype

• Medically healthy

• Singleton gestation

Exclusion Criteria:

• Chronic use of drugs for medical disorders, except thyroid replacement for stable hypothyroidism

• No psychiatrist or obstetrician

• QIDS-SR 16 positive answer 3 on item 12, "I have made specific plans for suicide or have actually tried to take my life" within the past week

• DSM-V diagnosis of substance abuse or dependence in last 6 months, with the exception of cannabis; positive urine drug screen