Pregnancy Clinical Trial
Official title:
Defining Factors Responsible for Temporal Changes in CYP3A4-Mediated Drug Metabolism During Pregnancy
Verified date | September 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 30, 2023 |
Est. primary completion date | June 30, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Chronic use of prescription or over the counter durgs during pregnancy with the exceptions listed under inclusions - Substance dependence in the last 6 months - Suicidal ideation with intent or suicide attempt in the last 6 months |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University Asher Center for the Study and Treatment of Depressive Disorders | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | University of Illinois at Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in thyroid hormone levels in plasma | Between 12-15 weeks, 22-25 weeks, 32-35 weeks and 12-15 months postpartum. |
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