Trazodone

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 Trazodone 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 35 / 956
Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.
Chan (Controls unexposed, pop general)
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 Trazodone 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 35 / 462377
Study data were obtained from the Clinical Data Analysis and Reporting System, a database that contains prescribing/dispensing records.
Einarson
2009 		Canada
Not specified.
prospective cohort 		The Motherisk Program, a teratogenic information service. Pregnant women who were exposed to Trazodone in the first trimester of pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnant women who were not exposed to antidepressants and who had called Motherisk for information regarding nonteratogenic drugs. 		1st trimester 17 / 928
During the initial telephone contact, details of exposure and concurrent exposures are recorded on a standardized questionnaire.
Khazaie (Controls exposed to diphenhydramine)
2013 		Iran
2008 - 2012
randomized controlled trial 		A randomized placebo-controlled clinical trial conducted at Kermanshah University of Medical Sciences (KUMS). Pregnant participants that received a single dose of trazodone (50 mg/day). exposed to other treatment, sick
Pregnant participants that received a single dose of diphenhydramine (25 mg/day). 		3rd trimester 18 / 19 The psychiatric interview was performed to exclude volunteers with any other psychiatric disorder such as baseline depression, as well as to confirm the diagnosis of insomnia for which participants were originally referred for treatment.
The subjects were randomly assigned to one of three treatment groups. Medications were self-administered 1 h before bedtime. Participants were blind to their treatment type throughout the study.
Khazaie (Controls unexposed, sick)
2013 		Iran
2008 - 2012
randomized controlled trial 		A randomized placebo-controlled clinical trial conducted at Kermanshah University of Medical Sciences (KUMS). Pregnant participants that received a single dose of trazodone (50 mg/day). unexposed, sick
Pregnant participants that received a single dose of placebo. 		3rd trimester 18 / 18 The psychiatric interview was performed to exclude volunteers with any other psychiatric disorder such as baseline depression, as well as to confirm the diagnosis of insomnia for which participants were originally referred for treatment.
The subjects were randomly assigned to one of three treatment groups. Medications were self-administered 1 h before bedtime. Participants were blind to their treatment type throughout the study.
Ozturk
2016 		Turkey
2007 - 2012
prospective cohort 		An observational cohort study based on a prenatal consultation service. Pregnant women exposed to Trazodone during pregnancy. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Pregnant women selected from the non-teratogen exposed pregnancies in the same year. 		at least 1st trimester 1 / 275 'Drug exposures took place in 81% during the first trimester, and 11% in all three trimesters. Medical treatments were discontinued in most of recognized pregnancies.'=> considered as 'At least first trimester'.
At the first contact, initiated via gynecologists, a detailed patient history form was used to notably record all drug exposures (dose, duration and timing in pregnancy).
Palmsten a (Controls exposed to SSRIs)
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The US nationwide Medicaid Analytic eXtract (MAX). Pregnant women with a depression diagnosis and a dispensation of Trazodone in monotherapy during the exposure window. exposed to other treatment, sick
Pregnant women with a depression diagnosis and a dispensation of selective serotonin reuptake inhibitor (SSRI) in monotherapy during the exposure window. 		2nd and/or 3rd trimester 339 / 19000 Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Outpatient pharmacy-dispensing data.
Palmsten a (Controls unexposed, sick)
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The US nationwide Medicaid Analytic eXtract (MAX). Pregnant women with a depression diagnosis and a dispensation of Trazodone in monotherapy during the exposure window. unexposed, sick
Pregnant women with a depression diagnosis and no antidepressant exposure between the LMP and the end of the window. 		2nd and/or 3rd trimester 339 / 59219 Women who received only one antidepressant class during the window were classified as having either SSRI, SNRI, tricyclic, bupropion or other antidepressant (mirtazapine, nefazodone, trazodone) monotherapy.
Outpatient pharmacy-dispensing data.
Palmsten b
2013 		USA
2000 - 2007
retrospective cohort (claims database) 		The Medicaid Analytic eXtract (MAX) data Women with a supply of Trazodone monotherapy that overlapped with the delivery date. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed, sick
Women who had no supply of antidepressants in the five months before delivery. 		late pregnancy 139 / 69044 Exclusion of women who were exposed to both drugs types (polytherapy) during the five months before delivery.
Data of prescription.
Yaris
2005 		Turkey
1999 - 2004
prospective cohort 		Toxicology Information and Follow-up Service Women who were exposed to Trazodone during pregnancy for depression, anxiety, and psychotic disorders. (This is a subgroup of exposure among the whole exposed group considered in the study). unexposed (general population or NOS)
Women who did not use any drug while pregnant. 		during pregnancy (anytime or not specified) 1 / 248 Raw data for Intrauterine exitus not reported because the nb of cases in the unexposed group not clearly stated. Raw data for premature delivery not reported because the denominator is not clearly stated.
Data surveyed by the interviews.

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
Anderson
2020 		USA
1997 - 2011
case control 		The National Birth Defects Prevention Study (NBDPS), a US population-based, multisite case-control study. The case infants were infants born alive or died at 20 SG or more and who had received a diagnosis of at least one selected birth defect. The controls were live-born infants with no major birth defects who were randomly selected from hospital or state birth-certificate records from the same geographic areas. Information on exposure to SSRIs and other potential risk factors during pregnancy were collected by standardized telephone interviews with mothers of case and control infants, conducted 6 weeks to 24 months after the EDD. 1st trimester 30630 / 11478 'Infants with recognized or strongly suspected chromosomal abnormalities or single-gene conditions were excluded from the study.'
Case infants were ascertained through population-based birth-defects surveillance systems in 10 U.S. states. Controls were selected randomly from the same geographic areas. Clinical data were abstracted from medical records and classified by clinician geneticists and other clinicians.
Laspro
2024 		USA
2013 - 2023
nested case control 		EPIC Cosmos, a database incorporating health information of 180 million patients, throughout the United States from approximately 180 US institutions utilizing EPIC medical records. Newborns with oral clefts (ICD 10 codes Q35 or Q36 or Q37). Newborns without oral clefts. Gestational medication use was identified by medications, prescribed, provider-administered, or reported use by mothers at any point during pregnancy. during pregnancy (anytime or not specified) 12098 / -9 P-values were calculated, while to account for multiple testing (693 hypotheses) Benjamini- Hochberg (BH) corrections were performed with a false discovery rate (Q) of 0.05.
Oral cleft cohorts were isolated using a combination of ICD codes, from the EPIC medical records.

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

master protocol

- About - Master protocol - Browse exposition - RSS - Made with in Lyon - Contact us - Privacy policy - Licence Creative Commons