Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
研究概览
简要总结
The purpose of this study is to evaluate the effect of escitalopram after 12 weeks of treatment in patients with Social Anxiety Disorder (SAD), to evaluate proportion of patients who respond to escitalopram during the treatment period, and to evaluate safety of escitalopram.
详细描述
The study will be performed in Russia, as an open-label, uncontrolled, one arm trial. The patients will receive escitalopram for 12 weeks. Start and maintenance dosages as well as dose titration will be left to the investigators' decision (5 to 20 mg/day), in accordance with the national Summary of Products Characteristics (SPC).
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient suffers from SAD, diagnosed according to ICD-10 (International Classification of Diseases)
- •The patient meets criteria set in the national SPC for escitalopram
- •The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history and vital signs
排除标准
- •The patient has/has had an alcohol or drug abuse-related disorder, as defined in ICD-10
- •The patient has contraindications to escitalopram
- •The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram
- •The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance
- •The patient is pregnant or breast-feeding
- •The patient, if a woman of childbearing potential, is not using adequate contraception
研究组 & 干预措施
Escitalopram
干预措施: Escitalopram (Drug)
结局指标
主要结局
Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
时间窗: baseline and 12 weeks
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
次要结局
- Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)(baseline and 12 weeks)
- Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2(baseline and 12 weeks)
- Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family(baseline and 12 weeks)
- Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social(baseline and 12 weeks)