EUCTR2008-005353-38-FR进行中（未招募）1 期
Interventional, randomised, double-blind, placebo-controlled, active reference (fluoxetine), fixed-dose study of vortioxetine in paediatric patients aged 7 to 11 years, with Major depressive disorder (MDD)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
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
- •- The patient is a boy or girl, aged =7 and <12 years at screening (patients who turn 12 years during the study will be allowed to continue in the study).
- •- The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
- •- The patient has a CDRS-R total score =45 at the Screening Visit and the Baseline Visit.
- •- The patient has a CGI-S score =4 at the Screening Visit and the Baseline Visit.
- •- The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 750
- •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
- •- The patient has participated in a clinical study <30 days prior to the Screening Visit.
研究者
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