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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
Boston Children's Hospital
Information provided by (Responsible Party):
Lee S. Cohen, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease
Major Depressive Disorder

Detailed Description:

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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Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

Adult Participants
Child Participants

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This study will be composed of two components: a maternal assessment based at Massachusetts General Hospital (MGH) and a child evaluation based at Boston Children's Hospital. Mother and child pairs may elect to complete both components of the study. If either participant does not want the child to take part in the research, the maternal component may be completed alone. Similarly, the child may enroll in the research study without the enrollment of the mother with parental consent.

Women who are interested and eligible for the study may choose to complete the study in-person at MGH or to be evaluated remotely by a phone interview and set of online surveys. All child subjects must participate in an in-person visit at Boston Children's Hospital.


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

Information from the National Library of Medicine

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

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Boston Children's Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Boston Children's Hospital
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Principal Investigator: Lee S Cohen, MD Massachusetts General Hospital
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Responsible Party: Lee S. Cohen, MD, Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02715778    
Other Study ID Numbers: 2015P001326
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders