Sponsor study identifier
observational
95
1 country
2
Study Start
February 2016
Actual (reported)Primary Completion
September 2017
Actual (reported)Study Completion
June 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2016
Actual (reported)February 5, 2016
Actual (reported)March 22, 2016
Actual (reported)September 2017
Actual (reported)June 2019
Actual (reported)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)
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.
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Lee S Cohen, MD
Massachusetts General Hospital
95 participants (actual enrollment reported by the registry).
First Submitted
February 5, 2016
First Posted
March 22, 2016
Study Start
February 2016
Actual (reported)Trial of a Positive Psychology Intervention in Major Depressive Disorder
Contact the study team to confirm eligibility.
Primary Completion
September 2017
Actual (reported)Study Completion
June 2019
Actual (reported)Last Updated
March 16, 2020
Record last verified: 2020-03
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Source: ClinicalTrials.gov.
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