A Retrospective And Multicenter Survey To Investigate The Dosage, Efficacy And Safety Of Sertraline In Posttraumatic Stress Disorder Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
研究概览
简要总结
This is a multicenter retrospective study to investigate the dosage regimens of sertraline in the treatment of Posttraumatic Stress Disorder (PTSD) under current medical practice and the efficacy and safety of this drug in patients with PTSD. Data will be collected from the medical records of patients with PTSD.
详细描述
Patients with PTSD who have been dosed with sertraline from July 2006 (i.e., the start of marketing of this drug in Japan) or later to before contracting with each investigational site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with PTSD who have been dosed with sertraline since July 2006 or later.
- •Patients must be Japanese.
- •Patients should be started before the conclusion of a contract with each investigational site.
排除标准
- •Not applicable.
研究组 & 干预措施
sertraline (Zoloft)
干预措施: sertraline (Zoloft) (Drug)
结局指标
主要结局
Clinical Global Impression - Improvement (CGI-I) at End of Administration/Observation
时间窗: Up to 6 years
Number of participants in each category of CGI-I at end of administration/observation. CGI-I is a 7-point clinician-rated scale, ranging from (1) Very much improved, (2)Much improved, (3) Minimally improved, (4) No change, (5) Minimally worse, (6) Much worse, and (7) Very much worse.
Clinical Global Impression of Severity (CGI-S) at Start of Administration/Observation
时间窗: Start of administration
Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Clinical Global Impression of Severity (CGI-S) at End of Administration/Observation
时间窗: Up to 6 years
Number of participants in each category of CGI-S at start and end of administration/observation. CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
次要结局
未报告次要终点