Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
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|ClinicalTrials.gov Identifier: NCT02715778|
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 16, 2020
|Condition or disease|
|Major Depressive Disorder|
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.
|Study Type :||Observational|
|Actual Enrollment :||95 participants|
|Official Title:||Translational Investigation of Gestational Environment on Neurobehavioral Function in Children|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||June 2019|
- neuropsychological functioning as assessed by CANTAB research battery [ Time Frame: cross-sectional assessment at baseline (at 6-17 years of age, depending on subject's age at time of visit) ]Further information on CANTAB available at: http://www.cambridgecognition.com/academic/crs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715778
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Lee S Cohen, MD||Massachusetts General Hospital|