NCT04830241|UnknownFDA Drug
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Sponsor study identifier
observational
10,000
1 country
1
Study Start
March 25, 2021
Actual (reported)Primary Completion
April 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To better characterize the neonatal hypotonia associated with in utero exposure to antidepressants, so far limited to clinical cases, we will perform an observational retrospective pharmacovigilance study, using two databases. First, disproportionality analysis in Vigibase®, the World Health Organization global database, will be perform between antidepressant drugs and neonatal hypotonia . Second, narratives from the French National Pharmacovigilance Database will be extracted.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 25, 2021
Actual (reported)March 31, 2021
Actual (reported)April 5, 2021
Actual (reported)April 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
neonatal hypotonia
Identification and extractions of cases of neonatal hypotonia newborns following in utero exposure to antidepressant drugs
Case reported in the World Health Organization (WHO) pharmacovigilance database to April 1st 2021
Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of neonatal hypotonia newborns following in utero exposure to antidepressant drugs, with a chronology compatible with the drug toxicity
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
all neonatal hypotonia newborns cases associated with in utero exposure to antidepressant drugs retrived in the two pharmacovigilance database
Caen University Hospital
Caen, Normandy, 14000, France
First Submitted
March 31, 2021
First Posted
April 5, 2021
Study Start
March 25, 2021
Actual (reported)Primary Completion
April 15, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Early Improvement in Individual Symptoms and Response to Antidepressants in Patients With Major Depressive Disorder
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Study Completion
May 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 5, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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