A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 28
- 主要终点
- Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
研究概览
简要总结
Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be eligible to enter an open-label extension study.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder.
- •Patient's current depressive episode must be at least 12 weeks in duration
- •Patient must have a parent or caregiver who must agree to accompany the patient to all clinic visits.
排除标准
- •Patients who currently meet DSM-IV criteria for:
- •attention deficit-hyperactivity disorder
- •obsessive-compulsive disorder
- •posttraumatic stress disorder
- •bipolar disorder
- •pervasive developmental disorder
- •mental retardation
- •conduct disorder
- •oppositional defiant disorder
- •Patients who are considered a suicide risk (have active suicidal ideation), who have made a suicide attempt, or who have ever been hospitalized because of a suicide attempt.
研究组 & 干预措施
Escitalopram
Escitalopram 10mg once daily for three weeks, 10-20mg once daily for up to the remaining 5 weeks
干预措施: Escitalopram (Drug)
2
Placebo once daily for up to 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
时间窗: Baseline to end of week 8
Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113.
次要结局
- Clinical Global Impressions - Improvement(CGI-I score at the end of Week 8)