Optimizing Medication Management for Mothers With Depression
OPTI-MOM
1 other identifier
observational
88
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2015
CompletedFirst Posted
Study publicly available on registry
August 11, 2015
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedNovember 17, 2021
November 1, 2021
4.3 years
August 7, 2015
November 15, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Concentration-to-dose ratio of SSRI in plasma
Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
Secondary Outcomes (2)
Edinburgh Postnatal Depression Scale (EPDS) Scores
Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
Asberg Side Effects Scale
Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Northwestern Universitylead
- University of Pittsburghcollaborator
- The University of Texas Medical Branch, Galvestoncollaborator
- Marshfield Cliniccollaborator
Study Sites (4)
Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
Chicago, Illinois, 60611, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine L. Wisner, M.D., M.S.
Northwestern University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 7, 2015
First Posted
August 11, 2015
Study Start
August 1, 2016
Primary Completion
December 1, 2020
Study Completion
June 30, 2021
Last Updated
November 17, 2021
Record last verified: 2021-11