A Double-blind, Fixed-dose Study of Escitalopram in Adult 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
- 877
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
研究概览
简要总结
This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram in adult patients (18 to 65 years of age) with moderate to severe depression. Patients completing the study may be eligible to enter a long-term open-label extension study with escitalopram.
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, Investigator, Outcomes Assessor)
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
- •Patients must meet Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for Major Depressive Disorder.
- •The patient's current depressive episode must be at least 8 weeks in duration.
排除标准
- •Women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control.
- •Patients with a history of meeting DSM-IV-TR criteria for: a. any manic or hypomanic episode; b. schizophrenia or any other psychotic disorder; c. obsessive-compulsive disorder.
- •Patients who are considered a suicide risk
- •Patients with a history of seizures (including seizure disorder), stroke, significant head injury, central nervous system tumors, or any other condition that predisposes patients to a risk for seizure.
研究组 & 干预措施
2
Escitalopram low dose
干预措施: Escitalopram (Drug)
3
Escitalopram high dose
干预措施: Escitalopram (Drug)
1
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
时间窗: Change from baseline in MADRS total score at week 8
The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms).
次要结局
- Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8(Change from baseline in HAM-D at week 8)