- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02715778
Translational Investigation of Gestational Environment on Neurobehavioral Function in Children
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Boston Children's Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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.
Beskrivelse
Inclusion Criteria:
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Adult Participants
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Child Participants
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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neuropsychological functioning as assessed by CANTAB research battery
Tidsramme: cross-sectional assessment at baseline (at 6-17 years of age, depending on subject's age at time of visit)
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Further information on CANTAB available at: http://www.cambridgecognition.com/academic/crs
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cross-sectional assessment at baseline (at 6-17 years of age, depending on subject's age at time of visit)
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2015P001326
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