Study to begin to develop patient guidelines for the use of antidepressant medications in pregnancy and following birth

Jul 21 2004

The University of Arizona department of psychiatry is conducting a first-of-its kind study to begin to develop patient guidelines for the use of antidepressant medications in pregnancy and following birth.

Although depression is extremely common during pregnancy, little data exist regarding whether common antidepressant medications continue to be effective and safe for pregnant women and their unborn babies. More information about the pharmacokinetics (the absorption, distribution, metabolism and elimination) and pharmacodynamics (the biochemical and physiological effects of drugs and the mechanisms of their actions) of antidepressants in pregnancy and postpartum is vital for optimal treatment, according to UA researchers.

In response, the UA department of psychiatry's Women's Mental Health Program is seeking 20 pregnant women who are taking sertraline (Zoloft) for a study to determine whether the antidepressant dosing requirements for pregnant women are the same as their non-pregnant counterparts.

The study, Maternal Antidepressant Drug Research and Evaluation (MADRE), is funded by the U.S. Food and Drug Administration (FDA). The research team also includes members from the UA departments of obstetrics and gynecology, pharmacology; the Section of Neonatology; and the UA National Center of Excellence for Women's Health. The study's principal investigator is Dr. Marlene Freeman, director of the UA Women's Mental Health Research Program.

(Sertraline, a "selective serotonin reuptake inhibitor" (SSRI) used to treat depression, obsessive-compulsive disorders and panic attacks, was selected based on wide use, safety data in pregnancy and reports of low levels of exposure and lack of adverse events in breastfeeding infants.)

To be eligible, pregnant women ages 18-45 must be in their second trimester (or earlier) of pregnancy, and must be receiving treatment with sertraline. The clinicians will document subjects‚ weight and height, sertraline dose, side effects, and other information. Testing will be performed to ascertain genetic impact on the metabolism of sertraline.

Improved knowledge of antidepressant use in pregnancy is greatly needed, Freeman says. Untreated maternal depression in pregnancy after birth has a negative impact on the development and health of the baby. Maternal stress in humans is associated with lower birth weight and gestational age at birth and it has been associated with fetal hypoxia, low birth weight and miscarriage in animals. Infants of mothers who have suffered depressive episodes are more likely to develop insecure attachments and behavioral problems. Moreover, depressed mothers are less attuned to their infants, and disturbances in early mother-infant interactions predict poorer infant cognitive outcome at 18 months, according to previous studies.