Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 6 - Any |
| Updated: | 8/22/2018 |
| Start Date: | February 2016 |
| End Date: | June 2019 |
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.
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.
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.
Inclusion Criteria:
1. Maternal subjects:
- have a child between 6-17 years of age
- had a history of major depressive disorder (MDD) at the time of their pregnancy
of the above child
- are at least 18 years of age
2. Child subjects:
- are between 6-17 years of age
- are the children of women who fit the eligibility criteria described above and
have consented to participate in the study
- are able to provide informed assent and a parent or guardian is able and willing
to provide informed consent
We found this trial at
2
sites
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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