Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum

NCT02978534 | Completed

• 1 other identifier: 00201540
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

pregnant; quetiapine; bipolar; women; female; postpartum; seroquel; perinatal; manic-depressive

Outcome Measures

Primary Outcomes (1)

• Change in plasma concentration/elimination

  For patients taking the immediate release formulation, plasma levels will be obtained beginning at time 0 and at hours, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16. For patients on the extended release formulation, plasma levels will be obtained at time 0 and at hours 0.5, 1, 1.5, 2, 2,5, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, 22, and 24.

  2 timepoints during pregnancy (second and third trimesters), and at four and twelve weeks postpartum

Secondary Outcomes (9)

• Arterial and Venous Umbilical Cord Concentration of Quetiapine and 7-N-desalylquetiapine

  30 minutes

• Cerebrospinal Fluid (CSF) Quetiapine and 7-N-desalkyquetiapine Concentrations

  CSF to be obtained within 10 minutes of the epidural placement during labor

• Scores on Depression assessment, Inventory of Depression Symptomatology- Self Report (IDS-SR)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum

• Scores on anxiety scale, Generalized Anxiety Disorder (GAD-7)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum

• Scores on mania assessment, Young Mania Reporting Scale (YMRS)

  Participants will complete these assessments an average of every 10 weeks from the time they enter the study, up to 12 weeks postpartum.

Study Arms (1)

Quetiapine

Patients taking quetiapine during pregnancy are eligible to participate in the study. Their dose and plasma concentration levels of quetiapine will be monitored throughout pregnancy and up to three months postpartum.

Drug: Quetiapine

Interventions

Quetiapine DRUG

Quetiapine concentrations will be observed in women who have already (under the guidance of a physician) decided to continue taking Quetiapine for the treatment of Bipolar Disorder (any subtype) or Schizophrenia during pregnancy.

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women taking quetiapine for the purpose of mood stabilizing will be recruited broadly from Northwestern clinical services, including Internal Medicine, OB/GYN, Family Medicine, and Psychiatry, registries, and from the local Chicagoland community. Patients that sign consent, complete the evaluation and meet criteria will be enrolled into the study.

You may qualify if:

• Age 18-45 years
• Pregnant, second trimester
• English-speaking
• DSM-V diagnosis of Bipolar Disorder or Schizophrenia, any subtype
• Medically healthy
• Singleton gestation

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum specimen will be obtained to measure quetiapine and estradiol levels. Standard of care labs will be obtained on every participant that is eligible and signs informed consent. Participants will not have more than 50 ml of blood drawn every 8 weeks. Participants will also have the option to have blood drawn for DNA banking. Participants in the study that elect to receive analgesia for pain related to labor and have a spinal-epidural at Northwestern University will have CSF stored and banked for future analysis.

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Crystal T Clak, MD, MSc

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 1, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)