Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT01796132
Eligibility Criteria:
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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01796132
Study Brief:
Protocol Section:
NCT01796132