DepressionOPTI-MOMNCT02519790
Optimizing Medication Management for Mothers With Depression
An observational study of Depression and Pregnancy, run by Northwestern University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Depression, Pregnancy
- How many people
- 88 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2016to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, 60611
University of Texas Medical Branch
Galveston, Texas, 77555
Marshfield Clinic
Marshfield, Wisconsin
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Depression, Pregnancy
- Keywords
- Pregnancy, Depression, Anxiety, Mental Health, Women
- Medical subject headings
- Depression, Anxiety Disorders, Psychological Well-Being
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration-to-dose ratio of SSRI in plasma
Measured: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
Secondary outcomes (2)
Edinburgh Postnatal Depression Scale (EPDS) Scores
Measured: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
Asberg Side Effects Scale
Measured: Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2016
- Primary completionDec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, The University of Texas Medical Branch, Galveston, Marshfield Clinic
- Responsible party
- Principal investigator, Katherine Wisner, Northwestern University
- Investigators
- Katherine L. Wisner, M.D., M.S., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519790
- Sponsor's protocol ID
- 1U54HD085601-01
- Acronym
- OPTI-MOM
- Status last verified
- Nov 2021
- First submitted
- 7 Aug 2015
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Medication Management for Mothers With Depression
- ClinicalTrials.gov ID
- NCT02519790
- Acronym / sponsor ID
- OPTI-MOM / 1U54HD085601-01
- Conditions
- Depression, Pregnancy
- Keywords
- Pregnancy, Depression, Anxiety, Mental Health, Women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh, The University of Texas Medical Branch, Galveston, Marshfield Clinic
- Study start
- Aug 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration-to-dose ratio of SSRI in plasma
Time frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
2 secondary outcomes
Edinburgh Postnatal Depression Scale (EPDS) Scores
Time frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
Asberg Side Effects Scale
Time frame: Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine L. Wisner, M.D., M.S. principal investigator
Northwestern University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Pregnancy, run by Northwestern University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration-to-dose ratio of SSRI in plasma (time frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.