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
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Enrollment: 283
Study Start Date: September 1999
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Pittsburgh
Investigators
Principal Investigator: Katherine L. Wisner, MD MS University of Pittsburgh, Department of Psychiatry
  More Information

No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Katherine Wisner, Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00279370     History of Changes
Other Study ID Numbers: R01 MH60335, R01MH060335, DSIR AT-SO
Study First Received: January 17, 2006
Last Updated: September 30, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Pittsburgh:
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 July 28, 2014