Dosulepin / Dothiepin - Medication and Pregnancy KB

Dosulepin / Dothiepin

Exposed non-exposed, cohort studies

Study	Country Study period Study design	Data source	Exposure definition	Non-exposure definition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias
Chan (Controls exposed to SSRIs) 2024	China 2003 - 2018 retrospective cohort (claims database)	The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents.	Infants of women with prescription of Dothiepin only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	exposed to other treatment, sick Infants of women with prescription of Selective-serotonin-reuptake-inhibitors (SSRI) only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	1st trimester	83 / 956
Chan (Controls exposed to SSRIs) 2024	China 2003 - 2018 retrospective cohort (claims database)		Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.		1st trimester	83 / 956
Chan (Controls unexposed, general pop) 2024	China 2003 - 2018 retrospective cohort (claims database)	The Clinical Data Analysis and Reporting System (CDARS), an electronic health-record database developed by the Hospital-Authority which is a statutory body delivering government-subsidized, universal health coverage to all Hong Kong residents.	Infants of women with prescription of Dothiepin only filled during the first trimester and prescriptions filled before pregnancy but with duration overlapping the first trimester.	unexposed (general population or NOS) Infants of pregnant women who were not prescribed with any antidepressant within 90 days before the last menstrual period and during the first trimester.	1st trimester	83 / 462377
Chan (Controls unexposed, general pop) 2024	China 2003 - 2018 retrospective cohort (claims database)		Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.		1st trimester	83 / 462377
Heuvelman 2023	United Kingdom 1995 - 2017 retrospective cohort (claims database)	The UK Clinical Practice Research Datalink, a large, ongoing database of anonymised primary care medical records for patients registered with a general practice in the United Kingdom.	Women who had initiated or continued Dosulepin for the treatment of depressive symptoms during pregnancy.	unexposed, sick Women who did not initiate or who discontinue antidepressants during pregnancy.	during pregnancy (anytime or not specified)	451 / 16330	Dose–response relationships, sibling design and negative control for antidepressants use as a whole (not for the class of antidepressants).
Heuvelman 2023			The Clinical Practice Research Datalink (CPRD) contains an extensive code list to identify the name, formulation and dose of medications, which are mandatory fields in the prescription electronic record (according to protocol).		during pregnancy (anytime or not specified)	451 / 16330
Lee (Controls exposed to SSRI) 2025	China 2003 - 2018 retrospective cohort (claims database)	The Clinical Data Analysis and Reporting System (CDARS) of the Hospital Authority, Hong Kong.	Women filling at least one prescription of Dothiepin only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery.	exposed to other treatment, sick Women filling at least one prescription of any selective serotonin reuptake inhibitors (SSRI) only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery.	during pregnancy (anytime or not specified)	131 / 1465
Lee (Controls exposed to SSRI) 2025	China 2003 - 2018 retrospective cohort (claims database)		The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records.		during pregnancy (anytime or not specified)	131 / 1465
Lee (Controls unexposed, general pop) 2025	China 2003 - 2018 retrospective cohort (claims database)	The Clinical Data Analysis and Reporting System (CDARS) of the Hospital Authority, Hong Kong.	Women filling at least one prescription of Dothiepin only during pregnancy, that is the period between the date of the last menstrual period and the date of delivery.	unexposed (general population or NOS) Women who were not prescribed with any antidepressant during index pregnancy.	during pregnancy (anytime or not specified)	131 / 463440
Lee (Controls unexposed, general pop) 2025	China 2003 - 2018 retrospective cohort (claims database)		The Clinical Data Analysis and Reporting System (CDARS) that captures and links all clinical data, including prescribing and dispensing records.		during pregnancy (anytime or not specified)	131 / 463440

Case-control studies

Study	Country Study period Study design	Data source	Case	Control	Exposition	Exposition period	Sample size (exposed/unexposed) Or (case / control)	Remarks	Risk of bias

Risk of bias: : NA; : low; : moderate; : serious; : critical; : unclear;

Empty. There are no case-control studies available for this drug.

master protocol