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Optimizing Medication Management for Mothers With Depression (OPTI-MOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519790
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : October 2, 2019
Sponsor:
Collaborators:
University of Pittsburgh
The University of Texas Medical Branch, Galveston
Marshfield Clinic
Information provided by (Responsible Party):
Katherine Wisner, Northwestern University

Brief Summary:
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.

Condition or disease
Depression Pregnancy

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimizing Medication Management for Mothers With Depression
Study Start Date : August 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Concentration-to-dose ratio of SSRI in plasma [ Time Frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum ]

Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) Scores [ Time Frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum ]
  2. Asberg Side Effects Scale [ Time Frame: Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of women taking sertraline (Zoloft), fluoxetine (Prozac), citalopram (Celexa), or escitalopram (Lexapro) in pregnancy and postpartum in areas surrounding Chicago, IL; Pittsburgh, PA and Galveston, TX.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519790


Contacts
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Contact: Gabrielle A Mesches, M.S. 312-695-6684 gabrielle.mesches@northwestern.edu

Locations
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United States, Illinois
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders Recruiting
Chicago, Illinois, United States, 60611
Contact: Gabrielle A Mesches, M.S.    312-695-6684    gabrielle.mesches@northwestern.edu   
Contact: Barbara Sutcliffe    312-695-8441    b-sutcliffe@northwestern.edu   
Principal Investigator: Katherine L. Wisner, M.D., M.S.         
Principal Investigator: Catherine S. Stika, M.D.         
Principal Investigator: Alfred L. George, M.D.         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dawn Fischer, R.N.    412-641-5194    dfischer@mail.magee.edu   
Contact: Steve Caritis, M.D.    412-641-4874    scaritis@mail.magee.edu   
United States, Texas
University of Texas Medical Branch Recruiting
Galveston, Texas, United States, 77555
Contact: Elizabeth Welch, RN, BSN    409-747-6622    elwelch@UTMB.EDU   
Contact: Maged Costantine, M.D.       maged.costantine@osumc.edu   
United States, Wisconsin
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States
Contact: Alpa Shah, MD       shah.alpa@marshfieldclinic.org   
Contact: Sandy Freeman, CCRC    715-387-9059    freeman.sandra@marshfieldresearch.org   
Sponsors and Collaborators
Northwestern University
University of Pittsburgh
The University of Texas Medical Branch, Galveston
Marshfield Clinic
Investigators
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Principal Investigator: Katherine L. Wisner, M.D., M.S. Northwestern University
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Responsible Party: Katherine Wisner, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02519790    
Other Study ID Numbers: 1U54HD085601-01 ( U.S. NIH Grant/Contract )
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katherine Wisner, Northwestern University:
Pregnancy
Depression
Anxiety
Mental Health
Women
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders