Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
283 participants
OBSERVATIONAL
1999-09-30
2009-12-31
Brief Summary
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Detailed Description
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Participants in this observational study will not receive medication or treatment of any kind. Pregnant woman who are already taking medication for depression will be recruited, in addition to pregnant women who are not taking any medication. The participants will first undergo interviews to establish their psychiatric diagnoses. Subsequent interviews will be held to monitor levels of depressive symptoms, exposure to other substances that could potentially harm the fetus, levels of antidepressants in the blood, and dietary intake during pregnancy. Participants will report to the study site for these evaluations at Weeks 20, 30, and 36 of pregnancy. From Week 36 to Week 40, interviews will be conducted over the phone.
At birth, cord blood will be collected and the infant's cries will be recorded. The infant's development will be assessed at 2 weeks and 3, 6 ½, 12, 18, and 24 months postpartum. Mothers who take selective serotonin reuptake inhibitors (SSRIs) and are breastfeeding their children will report to the study site with their children at 1 month postpartum to measure the level of SSRIs in the infant's blood. In addition, digital photographs of the infant's face, profile, hands, and torso will be taken at 2 weeks and 3, 12, and 24 months postpartum. Additional face-only photographs of the infant will be taken at these times and at birth for further in-depth analyses of facial characteristics. Mother-child interactions will be videotaped at all postpartum assessments.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy
Exclusion Criteria
* Current substance use disorder
* Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes)
* Has not attended at least two prenatal visits at the 20-week intake point
18 Years
45 Years
FEMALE
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Katherine Wisner
Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies
Principal Investigators
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Katherine L. Wisner, MD MS
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh, Department of Psychiatry
Locations
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Women's Behavioral HealthCARE Program
Pittsburgh, Pennsylvania, United States
Countries
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References
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Gollan JK, Yang A, Ciolino JD, Sit D, Wisner KL. Postpartum anhedonia: Emergent patterns in bipolar and unipolar depression. Psychiatry Res. 2021 Dec;306:114274. doi: 10.1016/j.psychres.2021.114274. Epub 2021 Nov 9.
Wisner KL, Sit D, O'Shea K, Bogen DL, Clark CT, Pinheiro E, Yang A, Ciolino JD. Bipolar disorder and psychotropic medication: Impact on pregnancy and neonatal outcomes. J Affect Disord. 2019 Jan 15;243:220-225. doi: 10.1016/j.jad.2018.09.045. Epub 2018 Sep 18.
Yang A, Ciolino JD, Pinheiro E, Rasmussen-Torvik LJ, Sit DKY, Wisner KL. Neonatal Discontinuation Syndrome in Serotonergic Antidepressant-Exposed Neonates. J Clin Psychiatry. 2017 May;78(5):605-611. doi: 10.4088/JCP.16m11044.
Kim DR, Pinheiro E, Luther JF, Eng HF, Dills JL, Wisniewski SR, Wisner KL. Is third trimester serotonin reuptake inhibitor use associated with postpartum hemorrhage? J Psychiatr Res. 2016 Feb;73:79-85. doi: 10.1016/j.jpsychires.2015.11.005. Epub 2015 Nov 19.
Santucci AK, Singer LT, Wisniewski SR, Luther JF, Eng HF, Dills JL, Sit DK, Hanusa BH, Wisner KL. Impact of prenatal exposure to serotonin reuptake inhibitors or maternal major depressive disorder on infant developmental outcomes. J Clin Psychiatry. 2014 Oct;75(10):1088-95. doi: 10.4088/JCP.13m08902.
Sit D, Perel JM, Wisniewski SR, Helsel JC, Luther JF, Wisner KL. Mother-infant antidepressant concentrations, maternal depression, and perinatal events. J Clin Psychiatry. 2011 Jul;72(7):994-1001. doi: 10.4088/JCP.10m06461.
Sit D, Perel JM, Luther JF, Wisniewski SR, Helsel JC, Wisner KL. Disposition of chiral and racemic fluoxetine and norfluoxetine across childbearing. J Clin Psychopharmacol. 2010 Aug;30(4):381-6. doi: 10.1097/JCP.0b013e3181e7be23.
Wisner KL, Sit DK, Hanusa BH, Moses-Kolko EL, Bogen DL, Hunker DF, Perel JM, Jones-Ivy S, Bodnar LM, Singer LT. Major depression and antidepressant treatment: impact on pregnancy and neonatal outcomes. Am J Psychiatry. 2009 May;166(5):557-66. doi: 10.1176/appi.ajp.2008.08081170. Epub 2009 Mar 16.
Sit DK, Perel JM, Helsel JC, Wisner KL. Changes in antidepressant metabolism and dosing across pregnancy and early postpartum. J Clin Psychiatry. 2008 Apr;69(4):652-8. doi: 10.4088/jcp.v69n0419.
Other Identifiers
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