Antidepressant Use During Pregnancy
Recruitment status was Active, not recruiting
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Purpose
This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.
| Condition |
|---|
|
Depression |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Antidepressant Use During Pregnancy |
| Estimated Enrollment: | 300 |
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Pregnant women with or without active depression and with or without SSRI use in pregnancy
Inclusion Criteria:
- Less than 24 weeks pregnant at the time of study entry
- As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy
Exclusion Criteria:
- History of or current psychosis, bipolar disorder, or schizoaffective disorder
- 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
Contacts and Locations| United States, Pennsylvania | |
| Women's Behavioral HealthCARE Program | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Katherine L. Wisner, MD MS | University of Pittsburgh, Department of Psychiatry |
More Information
No publications provided by National Institute of Mental Health (NIMH)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Katherine Wisner, MD MS Principal Investigator, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00279370 History of Changes |
| Other Study ID Numbers: | R01 MH60335, DSIR AT-SO |
| Study First Received: | January 17, 2006 |
| Last Updated: | December 6, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
SSRI Exposure Pregnancy Infant Development |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013