A Double-blind, Randomized, Placebo-controlled, Multicentre, Relapse-prevention Study of Vortioxetine in Paediatric Patients Aged 7 to 11 Years With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 17
- 主要终点
- Time to Relapse in the Double-blind Period
研究概览
简要总结
The purpose of this study is to find out if vortioxetine is better than placebo (sugar pills) in preventing depression in children who improved when treated with vortioxetine.
详细描述
The study consists of a 12-week open-label, flexible-dose treatment period with vortioxetine, followed by a 26-week, randomized, double-blind, fixed-dose, placebo-controlled relapse-prevention period. There will be a safety follow up 4 weeks after the end of the 26-week double-blind treatment period.
The study population will include 'de novo' participants as well as 'rollover' participants from other paediatric vortioxetine studies 12709A (NCT02709655) and 12712A (NCT02871297), who, in the investigator's opinion, could benefit from continued treatment with vortioxetine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •De novo participants
- •The participant has a primary diagnosis of MDD according to DSM-5™ although co-morbid anxiety disorders will be permitted (except Post Traumatic Stress Disorder (PTSD) and Obsessive Compulsive Disorder (OCD)).
- •The participant has a CDRS-R total score ≥45 at the Screening and Baseline Visits.
- •The participant has a Clinical Global Impression - Severity of Illness (CGI-S) ≥4 at the Screening and Baseline Visit
排除标准
- •The participant receives ongoing current psychotherapy that is planned to be intensified. Interpersonal psychotherapy (IPT) or cognitive behavioural therapy (CBT) are not allowed.
- •The participant presents with, or has a history of, an Axis I (DSM-5TM) diagnosis of Bipolar Disorder, PTSD, OCD, Autism, Pervasive Developmental Disorder (PDD), or Schizophrenia or Schizoaffective Disorder.
- •The participant has a diagnosis of attention-deficit/hyperactivity disorder (ADHD) and is not maintained on a stable dose of a methylphenidate or amphetamine for a minimum of 4 weeks prior to the study treatment.
- •The participant has attempted suicide or is at significant risk of suicide
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Vortioxetine -open label treatment period
Vortioxetine - 5, 10, 15, and 20 mg/day, film-coated tablets, orally once daily.
Patients will receive a targeted dose of 10 mg/day vortioxetine, however the investigator has the possibility to adjust the dose in case of unsatisfactory response or in case of dose-limiting adverse events.
干预措施: Vortioxetine (Drug)
Vortioxetine -double-blind relapse prevention period
Vortioxetine - 5, 10, 15, and 20 mg/day, encapsulated film-coated tables, orally once daily.
In the double-blind period, the patients will continue on the same fixed dose as during the end of the open label period
干预措施: Vortioxetine (Drug)
Placebo -double-blind relapse prevention period
Placebo - encapsulated tablets, orally once daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Relapse in the Double-blind Period
时间窗: From randomization to Week 26 in the double-blind treatment period
Relapse was defined as either a total score ≥40 on the Children Depression Rating Scale Revised Version (CDRS-R) with a history of 2 weeks of clinical deterioration, or clinical deterioration as judged by the clinician. The CDRS-R is rated by a clinician following interviews with the child and parent and consists of 17 items out of which 3 items rate nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items are rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) are scored on a 5-point scale from 1 to 5. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total score ranges from 17 (normal) to 113 (severe depression).
次要结局
- Change From Baseline in Children's Depression Rating Scale - Revised Version (CDRS-R) Total Score at Week 26(Baseline, Week 26)
- Relapse Rate in the Double-blind Period: Percentage of Participants With Relapse(From randomization to Week 26 in the double-blind treatment period)
- Clinical Global Impression - Global Improvement (CGI-I) Score at Week 26(Week 26)
- Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Week 26(Baseline, Week 26)
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Week 26(Baseline, Week 26)
- Plasma Concentration of Vortioxetine(From randomization to Week 26 in the double-blind treatment period)