- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02519790
Optimizing Medication Management for Mothers With Depression (OPTI-MOM)
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15213
- University of Pittsburgh
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Texas
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Galveston, Texas, Forenede Stater, 77555
- University of Texas Medical Branch
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Wisconsin
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Marshfield, Wisconsin, Forenede Stater
- Marshfield Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Concentration-to-dose ratio of SSRI in plasma
Tidsramme: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Edinburgh Postnatal Depression Scale (EPDS) Scores
Tidsramme: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Asberg Side Effects Scale
Tidsramme: Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Katherine L. Wisner, M.D., M.S., Northwestern University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1U54HD085601-01 (U.S. NIH-bevilling/kontrakt)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret enhedsprodukt
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