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临床试验/NCT01479400
NCT01479400已完成不适用

Safety Study for Infants Who Exposed to Antipsychotics as Fetus

Central South University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
152
试验地点
1
主要终点
evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development

研究概览

简要总结

The primary aim of this prospective study is to evaluate the effect of antipsychotics on infant development especially neurobehavioral development which evaluated by the Bayley-III when mothers are treated with antipsychotics throughout their pregnancy.

详细描述

The neurodevelopmental effect of antipsychotics on fetus has always been a major concern for women who need antipsychotic treatments and are in their reproductive years. The fear of harmful effects from antipsychotic on fetus and unplanned pregnancy commonly causes non-adherence to treatments. Even for those who are willing to maintain their antipsychotic treatments during pregnancy, the fear of potential harmful effects from antipsychotic on fetus can still exist. It is well known that non-adherence to antipsychotic treatments in patients with schizophrenia can cause most to relapse and poor treatment response. The consequences of relapse not only increase personal suffering, but also increase family and societal burden.Clearly, it is important to evaluate the safety of antipsychotics during pregnancy. However, up to now, most information about antipsychotics on reproductive safety and the effects on infant development come from case reports, case series, and retrospective studies.So the study was to investigate the developmental effects of antipsychotics on infants who were exposed to as fetus.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 1 Day(Child)
性别
All
接受健康志愿者

入选标准

  • exposed to antipsychotic as fetus
  • no exposed to antipsychotic

排除标准

  • malformation
  • liver dysfunction
  • renal dysfunction
  • cardiovascular diseases

结局指标

主要结局

evidence of negative effects of antipsychotic on infant mental development confirmed by Bayley Scales of Infant and Toddler Development

时间窗: one year

次要结局

未报告次要终点

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Renrong Wu

primary investigator

Central South University

研究点 (1)

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