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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH060335 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-SO |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
Symptoms of major depressive disorder (MDD) include persistent sad mood, feelings of hopelessness or guilt, decreased energy, irritability, and more. If untreated, MDD can interfere with the ability to work, study, sleep, eat, and enjoy once pleasurable activities. MDD occurs most commonly in females between the ages of 25 and 44. This puts women of childbearing age at a particularly high risk for developing the disorder. However, very little research has been done to determine the safety of antidepressant use during pregnancy and how the medication may affect the baby. This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| SIGH-ADS | 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum | |
| Bayley Scales of Infant Development | 12, 28, 52, and 104 weeks postpartum |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women with or without active depression and with or without SSRI use in pregnancy
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| Name | Affiliation | Role |
|---|---|---|
| Katherine L. Wisner, MD MS | University of Pittsburgh, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Behavioral HealthCARE Program | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34837882 | Derived | 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. | |
| 30248632 | Derived | 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. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| 28570796 | Derived | 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. |
| 26692255 | Derived | 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. |
| 25373117 | Derived | 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. |
| 21824458 | Derived | 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. |
| 20631556 | Derived | 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. |
| 19289451 | Derived | 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. |
| 18426260 | Derived | 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. |