Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants During Pregnancy and Evaluate Newborn Outcomes
Study to Evaluate the Effectiveness of Certain Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants During Pregnancy and Evaluate Newborn Outcomes
The purpose of this study is to evaluate if during pregnancy, a common group of
 antidepressant medications (SSRI's) adequately treats the symptoms of depression and to
 evaluate if there are any effects of these medications on the newborn infant.
The amount or levels of some antidepressant medications in the blood (e.g. selective
 serotonin reuptake inhibitors or SSRIs) seem to be decreased during pregnancy. If the levels
 of SSRIs in the blood are low, the medication may not be adequately treating depression. The
 objective of our study is to evaluate whether pregnant women have decreased levels of SSRIs
 and a resultant decreased improvement of depression with SSRIs. We also want to evaluate
 whether variations in the genes related to how the body eliminates the SSRIs or how the SSRIs
 work influence the improvement in the depression pregnant women experience from these drugs.
 We will conduct a study in 100 pregnant women who are receiving fluoxetine (n = 25) or
 sertraline (n = 25) for the treatment of depression, who are not receiving any medication for
 depression (n = 25), or who are pregnant no history or treatment for depression (n= 25).
 Participants will be enrolled any time before 26 weeks of pregnancy. Blood samples will be
 collected for genetic analysis in all subjects, and for drug level measurements during
 pregnancy, at delivery, and post partum in the subjects taking antidepressant medication. We
 will also be monitoring monthly platelet serotonin levels in all groups. In addition, the
 scores of a rating scale to measure the severity of depression and two rating scales to
 measure the undesirable effects of the treatment will be obtained on enrollment and monthly
 for up to 12 weeks after delivery. Maternal and umbilical cord blood samples will be obtained
 at delivery for determination of SSRI levels, platelet serotonin levels (a marker that SSRIs
 are working), and for collection of neonatal DNA. After delivery all mothers will complete a
 survey about how she is feeling about herself and the baby, and the baby's behavior will be
 observed for a 1 hour time interval. Babies of mothers taking medication will have a blood
 sample drawn at 2-3 months after birth to measure the drug level as compared with cord blood
 sample at delivery. We plan to collect a breastmilk sample from the mothers in the medicated
 arms that have chosen to breastfeed. Clinical data related to pregnancy and neonatal health
 will be obtained from the prenatal and neonatal charts.
Inclusion Criteria:

 -  Pregnant woman between 18 and 40 years of age

 -  Have depression as their only mental health disorder

 -  Have been receiving fluoxetine or citalopram for the treatment of depression for at
 least one month on the day of study entry for patients in the fluoxetine and
 citalopram arms, or no pharmacological treatment for patients in the control arm

 -  ≤ 26 weeks pregnant by estimated date of confinement

 -  Ability to give informed consent

 -  Singleton pregnancy

 -  Pregnant women no history of depression

 Exclusion Criteria:

 -  Having any comorbid mental disorder other than generalized anxiety disorder as a
 secondary disorder

 -  History of or current epilepsy, endocrine, cardiac, pulmonary, renal or hepatic
 dysfunction that could negatively influence pregnancy and/or neonatal outcome

 -  Abusing alcohol or drugs

 -  Use of any self prescribed herbal treatments for depression