Open Label, Observational, Non-interventional Study for the Evaluation of Remission Rates in Patients With MDD Under Treatment With Various Anti-depressives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 851
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
研究概览
简要总结
Tools known as 'depression scales 'are widely used as assessments to evaluate a patient's response to treatment. The purpose of this study is the evaluation of the remission rates for patients with MDD. The evaluation will involve the use of HAM-D 17, and HAM-D 7 questionnaires and the comparison of those questionnaires.
详细描述
12 weeks random
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients
- •18-75 years old
- •Patients diagnosed with MDD according to DSM IV without psychotic symptoms
- •HAM-D17 > or = 18 on inclusion
- •Patients receiving treatment for the first time or changing treatment based on their doctor's decision
排除标准
- •Subjects with potentially problematic compliance
- •Subjects participating in an interventional trial within the last 3 months
结局指标
主要结局
Percentage of Participants With Remission Based on Hamilton Depression Scale (HAM-D)
时间窗: Week 12
Remission according to HAM-D: HAM-D17 score less than or equal to (=\<) 7 or a HAM-D7 score =\< 3. HAM-D17: standardized, clinician-administered rating scale; assesses 17 items characteristically associated with major depression. Individual items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4), with 0=none/absent and 4=most severe. Total score: 0 to 66; higher score indicates more depression. HAM-D7: subset of HAM-D17; assesses 7 items associated with major depression. Total score: 0 to 26; higher score indicates more depression.
次要结局
- Percentage of Participants With Remission Based on Beck Depression Inventory (BDI)(Week 12)
- Hamilton Depression Scale 17 (HAM-D17), HAM-D7 and Beck Depression Inventory (BDI)(Baseline, Week 12)
- Number of Participants With Residual Symptoms in Case of Non Remission(Week 12)