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
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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