NCT00306540已完成3 期
A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical Administered PTSD Scale (CAPS2)
研究概览
简要总结
The purpose of this study is to evaluate how effective quetiapine versus placebo is when added to an existing therapy, in reducing the symptoms of PTSD.
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
- Quadruple (Participant, Care Provider, 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
- •Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study
排除标准
- •History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)
研究组 & 干预措施
1
Active Comparator
Placebo Seroquel + existing therapy
干预措施: quetiapine fumarate placebo (Drug)
2
Experimental
Seroquel + existing therapy
干预措施: Quetiapine Fumarate (Drug)
结局指标
主要结局
Clinical Administered PTSD Scale (CAPS2)
次要结局
- Hamilton Depression Scale (HAM-D)
- Hamilton Anxiety Scale (HAM-A)
- Posttraumatic Stress Disorder Checklist (PCL)
- Clinical Global Impressions (CGI)
研究者
研究点 (1)
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