Molecular Basis of Altered Drug Metabolism During Pregnancy

NCT03654378 | Withdrawn

• 1 other identifier: NICHD-1 R01 HD089455-01A1
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of this application are to provide mechanistic understanding of altered drug metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A drug metabolized by CYP3A4, Quetiapine, will be the drug of choice mechanism to understand the enzyme's induction. Pregnant women currently on Quetiapine will be recruited. If the women enroll, the women will participate in four pharmacokinetic (PK) studies (one per trimester, and one postpartum).

Conditions

Pregnancy

Keywords

Quetiapine; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Change in concentration-to-dose ratio of Quetiapine in plasma

  Between 12-15 weeks, 22-25 weeks, 32-35 weeks and 12-15 months postpartum.

Secondary Outcomes (1)

• Change in thyroid hormone levels in plasma

  Between 12-15 weeks, 22-25 weeks, 32-35 weeks and 12-15 months postpartum.

Eligibility Criteria

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

Study Population

Community sample of women taking Quetiapine in areas surrounding Chicago, IL.

You may qualify if:

• Age 18-45 years
• Pregnant, prior to 16 weeks gestation
• No chronic diseases or chronically administered medication
• Singleton or multiple gestation
• Subject may take aspirin, folate/multivitamins and other approved concomitant medications
• Taking Quetiapine for any clinical indication during pregnancy and postpartum
• Has made decision for Quetiapine treatment with prescriber prior to study entry

You may not qualify if:

• Substance dependence in the last 6 months
• Suicidal ideation with intent or suicide attempt in the last 6 months

Sponsors & Collaborators

• Northwestern University: lead
• University of Illinois at Chicago: collaborator

Study Sites (1)

Northwestern University Asher Center for the Study and Treatment of Depressive Disorders

Chicago, Illinois, 60611, United States

Location

Study Officials

• Katherine L Wisner, M.D., M.S.

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Hyunyoung Jeong, PharmD, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 31, 2018
• Study Start: August 1, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

US (1)