Major Depressive Disorder Clinical Trial
Official title:
Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
Although the last decade has brought major advances with respect to our knowledge of certain risks associated with fetal exposure to psychiatric medications, critical information regarding the long-term neurobehavioral impact of fetal exposure is lacking. With a prevalence rate of selective serotonin reuptake inhibitor (SSRI) use across pregnancy in Western countries noted to be as high as 5-8%, this study aims to close the gap in knowledge regarding long-term neurobehavioral sequelae of in utero exposure to this class of antidepressants. Importantly, the assessment of the impact of antenatal psychotropic medication use must be conducted with an appreciation of the potential direct and indirect effects of maternal psychiatric illness during pregnancy and throughout childhood. The outcomes of this study will help to inform the care of reproductive age women treated with psychiatric medications as they, along with the clinicians prescribing for them, weigh the relative risks of using these agents during pregnancy.
Neuropsychological evaluation of older children than previously studied with histories of
fetal exposure to antidepressants and maternal depression during pregnancy is needed and may
inform whether a signal for neural disruption exists following fetal selective serotonin
reuptake inhibitor (SSRI) exposure. Identification of genetic factors which may afford
resilience or particular vulnerability to fetal exposure to antidepressants is a logical
component of this translational initiative designed to answer the proposed research question.
Because of the hypothesis that prenatal exposure to gamma-aminobutyric acid (GABA)-based
drugs has the influence excitatory/inhibitory balance and to shift critical periods, there is
reason to believe that some aspects of brain development may also be altered. To this end,
this project aims to "scan" a variety of brain functions that include memory, attention, and
executive functions; in addition, it will also examine the extent to which face and speech
processing are altered in the target sample.
This study will assess older children ages 6-17 with histories of fetal exposure to
antidepressants and/or maternal depression during pregnancy. It will evaluate child behavior
based on maternal report and utilize neuropsychological evaluation to inform whether a signal
for neural disruption exists following fetal SSRI or depression exposure. The
neuropsychological assessments will be paired with an analysis of genetic factors which may
afford resilience or particular vulnerability to fetal exposure to antidepressants.
This study leverages unique patient resources with respect to children of mothers with well
documented histories of SSRI exposure who have been prospectively followed across pregnancy.
The multidisciplinary collaboration between the lead investigator, Dr. Lee S. Cohen of the
Center for Women's Mental Health (CWMH), and the Laboratories of Cognitive Neuroscience,
Boston Children's Hospital (Dr. Charles Nelson), the Department of Molecular and Cellular
Biology, and the Psychiatric and Neurodevelopmental Genetics Unit at Massachusetts General
Hospital (Dr. Jordan Smoller) is a remarkable opportunity to better understand the effects of
maternal antidepressant exposure during pregnancy on neuropsychological development of
children.
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