Long-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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 662
- 试验地点
- 78
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
Evaluation of the long-term safety and tolerability of vortioxetine in child and adolescent participants 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is a male or female child aged ≥7 and <12 years or adolescent aged ≥12 and ≤18 years in the lead-in study (12709A and 12710A).
- •The participant must have completed Study 12709A or 12710A (Visit 12, Completion Visit) immediately prior to enrolment into this extension study.
- •The participant had a primary diagnosis of MDD at entry in study 12709A or 12710A, diagnosed according to DSM-5™.
- •The participant is indicated for long-term treatment with vortioxetine according to the clinical opinion of the Investigator.
- •For participants aged ≥7 and ≤17 years at the Baseline visit; the participant is able to understand the Informed Assent Form, and parent(s)/legal representative(s) are able to read and understand the Informed Consent Form.
- •For participants who turned 18 years during the lead-in study 12710A; the participant has signed the Informed Consent Form.
排除标准
- •The participant has been diagnosed with another psychiatric disorder (for example mania, bipolar disorder, schizophrenia or any psychotic disorder) during study 12709A or 12710A.
- •The participant 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
Vortioxetine tablets for 26 weeks. Single dose of vortioxetine oral drops (only a subset of participants).
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline up to Week 30
An adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAE was defined as an AE that started or increased in intensity on or after the date of first dose of study drug in this study 12712A. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.
次要结局
- Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 26(Baseline, Week 26)
- Adolescents (12-18 Years): Change From Baseline in BRIEF-SR Using the MI Score at Week 26(Baseline, Week 26)
- Number of Participants With Response to the Palatability Questionnaire(assessed at Baseline up to Week 26, Week 26 reported)
- Time to First Relapse(Baseline up to Week 26)
- Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Week 26(Baseline, Week 26)
- Change From Baseline in Pediatric Quality of Life Inventory Present Functioning Visual Analogue Scale (PedsQL VAS) Total Score at Week 26(Baseline, Week 26)
- Time to First Loss of Remission(Baseline up to Week 26)
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26(Baseline, Week 26)
- Children (7-11 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Preschool (BRIEF-P) Using the Global Executive Composite (GEC) Score at Week 26(Baseline, Week 26)
- Clinical Global Impression - Global Improvement (CGI-I) Score(Week 26)
- Adolescents (12-18 Years): Change From Baseline in Behaviour Rating Inventory of Executive Function - Self-report (BRIEF-SR) Using the GEC Score at Week 26(Baseline, Week 26)
- Children (7-11 Years): Change From Baseline in BRIEF-P Using the MI Score at Week 26(Baseline, Week 26)
- Number of Participants With Response to the Acceptability Questionnaire(assessed at Baseline up to Week 26, Week 26 reported)