Optimizing Medication Management for Mothers With Depression
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 8/25/2018 |
| Start Date: | August 2016 |
| End Date: | June 2021 |
| Contact: | Minaz K Cattan, M.D. |
| Email: | minaz.kolia@northwestern.edu |
| Phone: | 312-695-7190 |
The purpose of this study is to explore the way the antidepressant concentration (amount of
medication) in the blood changes due to the physiological changes in the body (i.e., changes
in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of
genetic factors on the degree of these changes. Changes in antidepressant concentration are
important to monitor, as decreases in antidepressant concentration may lead to less than
therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of
depressive episodes. Increases in antidepressant concentration have the potential to lead to
increased side effects. The study team is hoping to better understand the course of these
changes across pregnancy and postpartum and how an individual's genetic makeup impacts these
changes with the goal of developing guidelines to optimize antidepressant treatment of
pregnant women.
medication) in the blood changes due to the physiological changes in the body (i.e., changes
in metabolism, hormones and body fluid) during pregnancy and postpartum and the impact of
genetic factors on the degree of these changes. Changes in antidepressant concentration are
important to monitor, as decreases in antidepressant concentration may lead to less than
therapeutic drug levels, which may cause an increase in mood symptoms or recurrence of
depressive episodes. Increases in antidepressant concentration have the potential to lead to
increased side effects. The study team is hoping to better understand the course of these
changes across pregnancy and postpartum and how an individual's genetic makeup impacts these
changes with the goal of developing guidelines to optimize antidepressant treatment of
pregnant women.
The overarching goal of this The Eunice Kennedy Shriver National Institute of Child Health
and Human Development (NICHD) funded U54 Obstetric-Fetal Pharmacology Research Center study
is to develop evidence to construct guidelines for the optimal use of selective serotonin
reuptake inhibitor (SSRI) antidepressants in pregnant women. The progressive changes in
plasma SSRI and metabolite concentrations across pregnancy and after birth will be determined
in an observational study. Serial evaluations of depressive and anxiety symptoms and side
effects will be obtained to evaluate their association with plasma concentrations at monthly
intervals during pregnancy and twice post-birth. To assess the subjects' metabolic
phenotypes, subjects have the option to receive a probe drug cocktail, which will be given to
evaluate the activities of enzymes involved in antidepressant metabolism during the third
trimester (when activity change is maximal) compared to the non-pregnant state after birth.
Additionally, the study team will investigate the impact of genomic variability on
inter-individual differences in SSRI dosing, plasma concentrations and pharmacodynamics
during pregnancy, with a focus on genes involved in the metabolism and elimination of SSRIs,
drug transporters responsible for SSRI access to the central nervous system, and genes
encoding critical SSRI targets involved in therapeutic efficacy.
Finally, the study team will determine the maternal-fetal plasma concentrations and
pharmacogenetic characteristics associated with neonatal SSRI abstinence syndrome. Maternal
and fetal genotypes will be assessed for their relationship to SSRI drug concentrations and
neonatal abstinence syndrome.
and Human Development (NICHD) funded U54 Obstetric-Fetal Pharmacology Research Center study
is to develop evidence to construct guidelines for the optimal use of selective serotonin
reuptake inhibitor (SSRI) antidepressants in pregnant women. The progressive changes in
plasma SSRI and metabolite concentrations across pregnancy and after birth will be determined
in an observational study. Serial evaluations of depressive and anxiety symptoms and side
effects will be obtained to evaluate their association with plasma concentrations at monthly
intervals during pregnancy and twice post-birth. To assess the subjects' metabolic
phenotypes, subjects have the option to receive a probe drug cocktail, which will be given to
evaluate the activities of enzymes involved in antidepressant metabolism during the third
trimester (when activity change is maximal) compared to the non-pregnant state after birth.
Additionally, the study team will investigate the impact of genomic variability on
inter-individual differences in SSRI dosing, plasma concentrations and pharmacodynamics
during pregnancy, with a focus on genes involved in the metabolism and elimination of SSRIs,
drug transporters responsible for SSRI access to the central nervous system, and genes
encoding critical SSRI targets involved in therapeutic efficacy.
Finally, the study team will determine the maternal-fetal plasma concentrations and
pharmacogenetic characteristics associated with neonatal SSRI abstinence syndrome. Maternal
and fetal genotypes will be assessed for their relationship to SSRI drug concentrations and
neonatal abstinence syndrome.
Inclusion Criteria:
- Age 18-45
- Pregnant, less than or at 18 weeks gestation
- English-speaking
- DSM-IV diagnosis of Major Depressive Disorder (MDD), any subtype
- Medically healthy
- Singleton gestation
- Taking sertraline (Zoloft), fluoxetine (Prozac), or citalopram (Celexa)/escitalopram
(Lexapro) and have made the decision to continue this medication throughout pregnancy
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder or any psychotic episode
- Substance abuse or dependence in the last 6 months and/or positive urine drug screen
- Primary anxiety disorder without MDD
- EPDS score ≥15, or item 10, self-harm thoughts, is scored 3 "yes, quite often"
- Current use of other therapies for depression, including herbals (such as St. John's
Wort)
- Chronic use of drugs for medical disorders except aspirin
- Allergy or adverse reaction to dextromethorphan, omeprazole, midazolam or tolbutamide
(exclusion for probe study only; these individuals may still participate in the main
study)
We found this trial at
3
sites
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Phone: 409-747-8234
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Phone: 412-641-5194
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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446 East Ontario Street
Chicago, Illinois 60611
Chicago, Illinois 60611
Principal Investigator: Katherine L. Wisner, M.D., M.S.
Phone: 312-695-7190
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