Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
Completed
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT02715778
- Run by
- Massachusetts General Hospital
- People needed
- 95
- Starts
- 2016-02-01
- Expected to finish
- 2019-06-01
- Last updated by the study team
- 2020-03-16
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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