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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

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What is being tested

SSRI/SNRI

Drug
Who is being recruted

Behavior+5

+ Mental Disorders

+ Behavioral Symptoms

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 4
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire Vaudois
Study ContactChantal Csajka, Prof PhDMore contacts
Last updated: July 28, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

see brief summary

NCT01796132
Principal SponsorCentre Hospitalier Universitaire Vaudois
Study ContactChantal Csajka, Prof PhDMore contacts
Last updated: July 28, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorMental DisordersBehavioral SymptomsFeeding BehaviorMood DisordersBreast FeedingDepressionDepressive Disorder

Criteria

5 inclusion criteria required to participate
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 under treatment by any SSRI/SNRI (fluvoxamine, fluoxetine, paroxetine, duloxetine, citalopram, escitalopram, sertraline or venlafaxine)
Mothers who intent to breastfeed their child
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5 exclusion criteria prevent from participating
Inability to communicate due to language problems for the mother
Infants of gestational age < 34 weeks
Mothers < 18 years of age patients
Mothers giving birth to infants with major malformations
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

No Intervention
Pregnant and/or nursing mothers not taking a SSRI or SNRI antidepressant are recruited in a non-exposed group (Control or no SSRI/SNRI). Control group participates only in the sub-studies related to neonatal adaptation, neurodevelopment, growth and early mother-infant relationship.

Group II

Experimental
Pregnant and/or nursing mothers under SSRI or SNRI treatment are recruited in an exposed group (SSRI/SNRI exposure). Drug regimen including dosage, frequency and duration is not modified by the study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Service d'Obstétrique, Service de Néonatologie; Centre Hospitalier Universitaire Nancy

Nancy, FranceOpen Service d'Obstétrique, Service de Néonatologie; Centre Hospitalier Universitaire Nancy in Google Maps
Recruiting

Service d'Obstétrique, Service de Néonatologie; Hospices civiles de Lyon (HCL)

Lyon, France
Recruiting

Service d'Obstétrique, Service du Développement et de la Croissance; Hopitaux Universitaires Genevois (HUG)

Geneva, Switzerland
Recruiting

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, Switzerland
Suspended5 Study Centers