Interventional, Randomized, 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)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 683
- 试验地点
- 98
- 主要终点
- Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B
研究概览
简要总结
Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).
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
- Double (Participant, Investigator)
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
- •The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5™).
- •The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.
- •The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.
- •The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit
- •The participant has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
排除标准
- •The participant has participated in a clinical study <30 days prior to the Screening Visit.
- •The participant has previously participated in a study with vortioxetine.
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Vortioxetine 10 mg/day
干预措施: Vortioxetine 10 mg/day (Drug)
Vortioxetine 20 mg/day
干预措施: Vortioxetine 20 mg/day (Drug)
Fluoxetine 20 mg/day,
A decision has been taken to stop recruitment into this treatment arm.
干预措施: Fluoxetine 20mg/day (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Children Depression Rating Scale - Revised (CDRS-R) Total Score at Week 8 of Phase B
时间窗: Baseline (Week 4 of Phase A), Week 8 of Phase B
The CDRS-R is a clinician-rated scale to measure the severity of depression in children and adolescents. The CDRS-R was rated by a clinician following interviews with the child and parent and consisted of 17 items out of which 3 items rated nonverbal observations (listless speech, hypoactivity, and depressed affect). Fourteen items were rated on a 7-point scale from 1 to 7, and 3 items (sleep disturbance, appetite disturbance, and listless speech) were scored on a 5-point scale from 1 to 5. A rating of 1 indicated normal functioning and a higher number indicated a greater degree of depression. The total score ranged from 17 (normal) to 113 (severe depression). Least square (LS) mean was estimated using a restricted maximum likelihood (REML)-based Mixed Model Repeated Measurements (MMRM) approach.
次要结局
- Change From Baseline in CDRS-R Total Score at Weeks 2, 4, and 6 of Phase B(Baseline (Week 4 of Phase A), Weeks 2, 4, and 6 of Phase B)
- Change From Baseline in CDRS-R Subscores (Mood, Somatic, Subjective, and Behaviour) at Weeks 2, 4, 6, and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B)
- Clinical Global Impression - Global Improvement (CGI-I) Score(Weeks 1, 2, 3, 4, 6, and 8 of Phase B)
- Percentage of Participants With CGI-S Remission(Weeks 1, 2, 3, 4, 6, and 8 of Phase B)
- Percentage of Participants With CDRS-R Response(Weeks 2, 4, 6, and 8 of Phase B)
- Percentage of Participants With CDRS-R Remission(Weeks 2, 4, 6, and 8 of Phase B)
- Change From Baseline in General Behaviour Inventory (GBI) Depression Subscale Score, Using the 10-Item Depression Subscale Assessed by Parent (PGBI-10D) and Child (CGBI-10D) at Weeks 2, 4, 6, and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 2, 4, 6, and 8 of Phase B)
- Parent Global Assessment (PGA) Score(Weeks 2, 4, 6, and 8 of Phase B)
- Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS: Tired (Fatigue) Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS: Pain or Hurt Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Weeks 1, 2, 3, 4, 6, and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 1, 2, 3, 4, 6, and 8 of Phase B)
- Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS: Sad or Blue (Sadness) Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS: Angry Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PQ-LES-Q Overall Evaluation Score (Item 15) at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS: Worry Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL VAS Total Average Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in PedsQL Emotional Distress Summary Average Score at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)
- Change From Baseline in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score (Items 1 to 14) at Weeks 4 and 8 of Phase B(Baseline (Week 4 of Phase A), Weeks 4 and 8 of Phase B)