Informations générales (source: ClinicalTrials.gov)
Antidepressant Treatments During Pregnancy and Lactation: Prediction of Drug Exposure Through Breastfeeding and Evaluation of Drug Effect on the Neonatal Adaptation and the Development of the Young Child
Interventional
Phase 4
Centre Hospitalier Universitaire Vaudois (Voir sur ClinicalTrials)
août 2012
décembre 2018
29 juin 2024
Background: The childbearing years are a time of increased vulnerability to the onset of
mood disorders in women and a high prevalence of exposure to antidepressant drugs during
pregnancy and postpartum has been reported. However, the lack of information regarding
the milk transfer and the safety of these drugs in breastfed infants and the related fear
of adverse events for the sucking infant are some of the factors responsible for stopping
prematurely breast-feeding or avoiding drug therapy. Selective serotonin reuptake
inhibitors (SSRI) and selective serotonin and noradrenaline reuptake inhibitors (SNRI)
are the most frequently prescribed antidepressant drugs during pregnancy and the
post-partum period. They exhibit a wide interpatient variability in their concentration
profiles that has been related to numerous environmental, stereochemical, demographic and
genetic influences that might alter the level of exposure of breastfed newborns. Limited
information is available regarding the safety of use of these antidepressant drugs during
lactation, and is generally derived from small studies. A comprehensive description of
their distribution and quantification in milk in a larger cohort of patients under
various influences and the resulting impact on milk concentrations is lacking.
Objectives: The current proposal addresses the primary objectives of quantifying the
range of concentration to citalopram, escitalopram, sertraline, fluoxetine, paroxetine,
fluvoxamine, duloxetine and venlafaxine in mother plasma and breast milk in relation to
genetic polymorphisms, stereochemistry, demographics and environmental factors in a large
cohort of depressive mothers. This will enable to derive the exposure to the breast-fed
child taking into account this variability and therefore better adjust treatment to
potential influences. As secondary objectives, we will examine the neurodevelopmental
outcome of a sub-set of infants subjected to SSRI/SNRI in utero and/or during
breastfeeding at birth, 6, 18 and 36 months, and compared to that of a control population
of infants not subjected to this treatment.
Expected Results: The proposed strategy will offer new information regarding the expected
level of drug exposure associated with each or with a combination of risk factors and
help for optimizing the security and rationalizing the use of antidepressant treatment in
lactating women. Hence, research on the safety of use of these drugs for the developing
child is an area of great public health significance.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service d'Obstétrique, Service de Néonatologie; Hospices civiles de Lyon (HCL) - Lyon - Rhône - France | Olivier Claris, Prof MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Service d'Obstétrique, Service de Néonatologie; Centre Hospitalier Universitaire Nancy - Nancy - Meurthe-et-Moselle - France | Jean-Michel Hascoët, Prof MD | Contact (sur clinicalTrials) | |||
Critères
Femme
Inclusion Criteria:
- Patients planning to deliver in the 5 maternities involved in the study;
- Mothers under treatment by any SSRI/SNRI (fluvoxamine, fluoxetine, paroxetine,
duloxetine, citalopram, escitalopram, sertraline or venlafaxine);
- Mothers who intent to breastfeed their child;
- Ability to understand and willingness to sign a written informed consent document
for plasma and milk withdrawal and pharmacogenetic testing.
- For the neurodevelopment follow-up part,all babies of the Maternity of Lausanne,
Morges or Geneva exposed to SSRI/SNRI will be enrolled. A control group of infants
of the same socio-economic status as the subset of exposed patients will be
recruited in the Maternity Hospital of Lausanne.
- Patients planning to deliver in the 5 maternities involved in the study;
- Mothers under treatment by any SSRI/SNRI (fluvoxamine, fluoxetine, paroxetine,
duloxetine, citalopram, escitalopram, sertraline or venlafaxine);
- Mothers who intent to breastfeed their child;
- Ability to understand and willingness to sign a written informed consent document
for plasma and milk withdrawal and pharmacogenetic testing.
- For the neurodevelopment follow-up part,all babies of the Maternity of Lausanne,
Morges or Geneva exposed to SSRI/SNRI will be enrolled. A control group of infants
of the same socio-economic status as the subset of exposed patients will be
recruited in the Maternity Hospital of Lausanne.
- Mothers <18 years of age patients;
- Infants of gestational age < 34 weeks;
- Mothers giving birth to infants with major malformations;
- Inability to communicate due to language problems for the mother;
- Patients with a socio-economic context making close monitoring of the child by the
mother or a relative not possible.