EUCTR2008-005356-25-IT进行中（未招募）1 期
ong-term, open-label, flexible-dose, extension study of vortioxetine in child and adolescent patients with Major Depressive Disorder (MDD) from 7 to 18 years of age
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
- 662
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 male or female child aged =7 and <12 years or an adolescent aged =12 and =18 years in the lead-in study (12709A and 12710A).
- •- The patient must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
- •- The patient had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
- •- The patient is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 850
- •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 been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
- •- The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.
研究者
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