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临床试验/EUCTR2012-004509-29-FR
EUCTR2012-004509-29-FR进行中(未招募)不适用

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 - SSRI Milk

Hospices Civils de Lyon0 个研究点目标入组 400 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • -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

排除标准

  • -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.

研究者

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