NCT03108625已完成3 期
Long-term, Open-label, Flexible-dose, Continuation Extension Study With Vortioxetine in Child and Adolescent Patients With Major Depressive Disorder (MDD) From 7 to 17 Years of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 31
- 主要终点
- Incidence of Treatment-Emergent Adverse Events (Safety)
研究概览
简要总结
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent patients with a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5™) diagnosis of MDD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is a male or female child aged ≥7 and <12 years or an adolescent aged ≥12 and ≤17 years at Baseline in Study 12712B.
- •The patient must have completed extension Study 12712A immediately prior to enrolment into this extension study.
- •The patient had a primary diagnosis of a MDD at entry in Study 12709A or 12710A, diagnosed according to DSM-5™.
- •The patient is still indicated for long-term treatment with vortioxetine according to the clinical opinion of the investigator.
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 12712A.
- •The patient has an attention-deficit/hyperactivity disorder (ADHD) that requires a pharmacological treatment other than a stimulant medication.
- •Other protocol-defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Vortioxetine
Experimental
Once daily dosing of vortioxetine (oral tablets) for 78 weeks.
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events (Safety)
时间窗: Up to Week 104
Based on safety assessments (e.g. paediatric adverse event rating scale (PAERS), clinical safety laboratory tests (including reproductive hormones), vital signs, weight, height, Tanner score, menstrual cycle, ECG, and C-SSRS
次要结局
- Change in CDRS-R total score(Change from study 12712A baseline to Week 104)
- Number of relapses (CDRS-R ≥40 with a history of 2 weeks of clinical deterioration)(Up to Week 104)
- Loss of remission (CDRS-R <28 with a history of 2 weeks of clinical deterioration)(Up to Week 104)
- Change in CGI-S score(Change from study 12712A baseline to Week 104)
- CGI-I score(Week 104)
- Children (7-11 years): change in BRIEF using the Global Executive Composite score(Change from study 12712A baseline to Week 104)
- Children (7-11 years): change in BRIEF using the Megacognition Index(Change from study 12712A baseline to Week 104)
- Adolescents (12-17 years): change in BRIEF-SR using the Global Executive Composite score(Change from study 12712A baseline to Week 104)
- Adolescents (12-17 years): change in BRIEF-SR using the Megacognition Index(Change from study 12712A baseline to Week 104)
- Change in CGAS score(Change from study 12712A baseline to Week 104)
- Change in PedsQL VAS score(Change from study 12712A baseline to Week 104)
研究者
研究点 (31)
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