NCT02709746已完成3 期
Interventional, Randomised, Double-blind, Placebo-controlled, Active Reference (Fluoxetine), Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years, With Major Depressive Disorder (MDD)
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
- 784
- 试验地点
- 124
- 主要终点
- Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
研究概览
简要总结
Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
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
- 12 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, aged ≥12 and ≤17 years at Screening (patients who turn 18 years during the study will be allowed to continue in the study).
- •The patient has Major depressive disorder (MDD), diagnosed according to DSM-5™.
- •The patient has a Children Depression Rating Scale - Revised (CDRS-R) total score ≥45 at the Screening Visit and at the Baseline.
- •The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≥4 at the Screening Visit and at the Baseline
- •The patient has provided assent to participation and parent(s)/legal representative (s) signed the Informed Consent Form.
排除标准
- •The patient has participated in a clinical study <30 days prior to the Screening Visit.
- •Other protocol defined inclusion and exclusion criteria may apply
研究组 & 干预措施
Vortioxetine 10 mg/day
Experimental
干预措施: Vortioxetine 10 mg/day (Drug)
Vortioxetine 20 mg/day
Experimental
干预措施: Vortioxetine 20 mg/day (Drug)
Fluoxetine 20 mg/day,
Active Comparator
干预措施: Fluoxetine 20 mg/day (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Change in Children Depression Rating Scale - Revised (CDRS-R) Total Score After Treatment
时间窗: From Randomization to Week 8
The CDRS-R is a clinician-rated scale to measure the severity of depression of children and adolescents. The CDRS-R consists of 17 items: 14 items rate verbal observations, and three items rate nonverbal observations (tempo of language, hypoactivity, and nonverbal expression of depressed affect). Depression symptoms are rated on a 5-point scale from 1 to 5 for the verbal observations, and a 7-point scale from 1 to 7 for the nonverbal observations. The total score ranges from 17 (normal) to 113 (severe depression).
次要结局
- Change in CDRS-R Total Score During Treatment (at Week 2)(At week 2)
- Change in CDRS-R Total Score During Treatment (at Week 4)(At week 4)
- Change in CDRS-R Total Score During Treatment (at Week 6)(At week 6)
- Change in CDRS-R Mood Score(From randomization to Week 8)
- Change in CDRS-R Somatic Score(From Randomization to Week 8)
- Change in CDRS-R Subjective Score(From Randomization to Week 8)
- Change in CDRS-R Behaviour Score(From Randomization to Week 8)
- CDRS-R Response(From Randomization to Week 8)
- CDRS-R Remission(From Randomization to Week 8)
- Change in General Behaviour Inventory (GBI) Depression Sub Scale Score Assessed by the Parents(From randomization to week 8)
- Change General Behaviour Inventory (GBI) Depression Subscale Score Assessed by the Child(From randomization to Week 8)
- Parent Global Assessment-Global Improvement (PGA) Score(From Randomization to Week 8)
- Change in Symbol Digit Modalities Test (SDMT)(From Randomization to Week 8)
- Change in Clinical Global Impression Severity of Illness (CGI-S) Score(From Randomization to Week 8)
- Clinical Global Impression - Global Improvement (CGI-I) Score(From Randomization to Week 8)
- CGI-S Remission(From Randomization to Week 8)
- Change in Children's Global Assessment Scale (CGAS) Score(From Randomization to Week 8)
- Change in Pediatric Quality of Life Inventory (PedsQL) Visual Analogue Scales (VAS): Afraid or Scared (Anxiety) Score(From Randomization to Week 8)
- Change in PedsQL VAS: Sad or Blue (Sadness) Score(From Randomization to Week 8)
- Change in PedsQL VAS: Angry Score(From Randomization to Week 8)
- Change in PedsQL VAS: Worry Score(From Randomization to Week 8)
- Change in PedsQL VAS: Tired (Fatigue) Score(From Randomization to week 8)
- Change in PedsQL VAS: Pain or Hurt Score(From Randomization to Week 8)
- Change in PedsQL VAS Total Average Score(From Randomization to week 8)
- Change in PedsQL Emotional Distress Summary Average Score(From Randomization to week 8)
- Change in Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Scores(From Randomization to Week 8)
- Change in PQ-LES-Q Overall Score(From Randomization to Week 8)
研究者
研究点 (124)
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