Status:
UNKNOWN
Antidepressants During Pregnancy and Lactation: Pharmacokinetics and Clinical Implications
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
University Hospital, Geneva
Hospices Civils de Lyon
Conditions:
Depressive Disorder
Lactation
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
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 postpart...
Detailed Description
see brief summary
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01796132
Start Date
August 1 2012
End Date
December 1 2018
Last Update
July 28 2015
Active Locations (5)
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1
Service d'Obstétrique, Service de Néonatologie; Centre Hospitalier Universitaire Nancy
Nancy, Meurthe-et-Moselle, France
2
Service d'Obstétrique, Service de Néonatologie; Hospices civiles de Lyon (HCL)
Lyon, Rhône, France
3
Service d'Obstétrique, Service du Développement et de la Croissance; Hopitaux Universitaires Genevois (HUG)
Geneva, Canton of Geneva, Switzerland
4
Division de Pharmacologie Clinique, Service d'Obstétrique, Service de Néonatologie, Service de Pédopsychiatrie de liaison, Unité de Pharmacogénétique et Psychopharmacologie Clinique; Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland