NCT01198795已完成4 期
An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder
Forest Laboratories16 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 16
- 主要终点
- Patients With Any Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients 7 to 11 years of age, inclusive
- •Current diagnosis of MDD based on DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) criteria as confirmed by K-SADS-PL (Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime) with a minimum duration of 6 weeks
- •Patient's parent(s), guardian(s), or LAR(s) is capable of providing information about his or her condition, provides informed consent, and agrees to accompany the patient to all study visits. (Preferably the same parent, guardian, or LAR will accompany the patient to all study visits)
- •Patient's family is sufficiently organized and stable to guarantee adequate safety monitoring
排除标准
- •Current principal DSM-IV-TR-based diagnosis of an axis I disorder other than MDD that was the primary focus of treatment
- •Patients with a diagnosis of conduct disorder will not be allowed to participate in this study
- •Current diagnosis of mental retardation, dementia, or amnestic or other cognitive disorders based on DSM-IV-TR criteria
- •History of allergy, intolerance, or hypersensitivity to escitalopram, citalopram, or other drugs of the same class
- •Imminent risk of injuring self or others or causing significant damage to property, as judged by the PI
- •Suicide risk as determined by meeting any of the following criteria:
- •Any suicide attempt
- •Significant risk, as judged by the PI, based on the psychiatric interview or information collected in the Columbia-Suicide Severity Rating Scale (C-SSRS)
研究组 & 干预措施
1
Experimental
Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Patients With Any Treatment Emergent Adverse Events (TEAEs)
时间窗: From Baseline (Week 0) to Week 26
The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period,
次要结局
未报告次要终点
研究者
研究点 (16)
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