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Antidepressant Use During Pregnancy
This study is ongoing, but not recruiting participants.
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00279370
  Purpose

This study will determine the safety of antidepressant use during pregnancy for both the mother and the child.


Condition
Depression

MedlinePlus related topics: Antidepressants Depression
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Antidepressant Use During Pregnancy

Further study details as provided by National Institute of Mental Health (NIMH):

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 300
Study Start Date: September 1999
Estimated Study Completion Date: December 2009
Detailed Description:

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
Study Population

Pregnant women with or without active depression and with or without SSRI use in pregnancy

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00279370

Locations
United States, Pennsylvania
Women's Behavioral HealthCARE Program
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Investigators
Principal Investigator: Katherine L. Wisner, MD MS University of Pittsburgh, Department of Psychiatry
  More Information

Click here for the Women's Behavioral HealthCARE website  This link exits the ClinicalTrials.gov site

Publications indexed to this study:
Responsible Party: University of Pittsburgh ( Katherine Wisner, MD MS Principal Investigator )
Study ID Numbers: R01 MH60335, DSIR AT-SO
Study First Received: January 17, 2006
Last Updated: December 6, 2007
ClinicalTrials.gov Identifier: NCT00279370  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
SSRI Exposure
Pregnancy
Infant Development

Study placed in the following topic categories:
Depression
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009