Antidepressant treatments during pregnancy and lactation: prediction of drug exposure through breastfeeding and evaluation of drug effect onthe neonatal adaptation and the development of the young child

• Conditions: depression; MedDRA version: 18.0Level: PTClassification code 10012378Term: DepressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2012-004509-29-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-15
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

-Planning to deliver in the Department of Obstetrics and Gynecology of the Hôpital Mère-Enfants (University Hospital of Lyon) or in the Department of Obstetrics and Gynecology of the University Hospital of Nancy;
-Under treatment by any SSNR/SSRI (fluvoxamine, fluoxetine, paroxetine, duloxetine, citalopram, escitalopram, sertraline or venlafaxine) without limitation of time since the start of treatment;
-Who intent to breastfeed their child;
-Having a health coverage;
-Without any legal protection measure;
-Having signed the written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Mothers <18 years of age patients
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified