Antidepressant Use During Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Katherine Wisner, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00279370
First received: January 17, 2006
Last updated: September 30, 2013
Last verified: September 2013

January 17, 2006
September 30, 2013
September 1999
December 2009   (final data collection date for primary outcome measure)
  • SIGH-ADS [ Time Frame: 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum ] [ Designated as safety issue: Yes ]
  • Bayley Scales of Infant Development [ Time Frame: 12, 28, 52, and 104 weeks postpartum ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00279370 on ClinicalTrials.gov Archive Site
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Antidepressant Use During Pregnancy
Antidepressant Use During Pregnancy

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Depression
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
283
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00279370
R01 MH60335, R01MH060335, DSIR AT-SO
No
Katherine Wisner, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Katherine L. Wisner, MD MS University of Pittsburgh, Department of Psychiatry
University of Pittsburgh
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP