Major Depressive Disorder Clinical Trial
Official title:
Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
NCT number | NCT02715778 |
Other study ID # | 2015P001326 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | June 2019 |
Verified date | March 2020 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | June 2019 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Boston Children’s Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | neuropsychological functioning as assessed by CANTAB research battery | Further information on CANTAB available at: http://www.cambridgecognition.com/academic/crs | cross-sectional assessment at baseline (at 6-17 years of age, depending on subject's age at time of visit) |
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