EUCTR2012-004546-15-FR进行中(未招募)1 期
Assessment of incidence of adverse events in a naive pediatric population treated with an antipsychotic drug over 12 months follow-up - Unwanted events in naive pediatric population treated by antipsychotic
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- CHU de Nice
- 入组人数
- 340
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
- All
入选标准
- •Male or female patients
- •6 •In whom antipsychotic treatment is indicated
- •Who have never been treated with antipsychotic medication (other than metoclopramide (Primperan®) for pediatric indications).
- •- Receiving an antipsychotic for less than 15 days
- •- Without history of exhibition in an antipsychotic or with a history of grip of antipsychotic of less than three consecutive months interrupted for more than six months before the inclusion
- •- Hospitalized ( e ) in full-time or day department, or seen ambulatory
- •- Obtaining of the lit consent, the patient and his parents or the legal person in charge
- •- Obtaining of the consent lit by the patient become major during the follow-up
- •- Membership in a national insurance scheme
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 340
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- 未提供
研究者
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