A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 273
- 试验地点
- 39
- 主要终点
- Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
研究概览
简要总结
This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation.
- •Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid).
- •Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
- •Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug.
- •Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol.
排除标准
- •Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder.
- •Suspected or previously diagnosed intellectual disability disorder.
- •One or more first-degree relatives with diagnosed bipolar I disorder.
- •History of seizure disorder (other than febrile seizures).
- •History of electroconvulsive therapy at any time during the subject's lifetime.
- •Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications.
- •Taking any medications that are contraindicated to escitalopram (escitalopram oxalate).
- •Inability to speak, read, or understand English well enough to complete the assessments.
- •No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
研究组 & 干预措施
Escitalopram 10 mg/day
Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion
干预措施: Escitalopram (Drug)
Placebo
Matching oral administration of placebo once daily
干预措施: Placebo (Other)
结局指标
主要结局
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
时间窗: Baseline to Week 8
The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
次要结局
- Response Rate on the PARS(Week 8)
- Remission Rate on the PARS(Week 8)
- Change on the Clinical Global Impression of Severity (CGI-S)(Week 8)
- Change on the Children's Global Assessment Scale (CGAS)(Week 8)