Secondary Prevention With Paroxetine vs. Placebo in Subthreshold Posttraumatic Stress Disorder (PTSD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Clinician Administered PTSD Scale (CAPS) Scores
研究概览
简要总结
The purpose of this study is: 1) To document the effectiveness and tolerability of paroxetine for the treatment of subthreshold posttraumatic stress disorder (PTSD) in veterans in the early post-deployment period; and 2) To determine the potential efficacy of paroxetine in preventing the progression of anxiety symptoms to PTSD and other anxiety disorders, and improving overall veteran function.
详细描述
See brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans 18-55 years of age
- •Diagnosis of subthreshold PTSD (at least one symptom in PTSD symptom clusters B, C, and D by structured interview; with or without functional impairment exposure to war zone stressors)
- •Written informed consent; and
- •A negative serum pregnancy test for women of childbearing potential.
排除标准
- •Lifetime history of DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition
- •History of substance dependence within the last 3 months
- •Significant suicide risk or serious suicide attempt within the last year
- •Clinically significant medical condition or laboratory or EKG abnormality
- •Women of childbearing potential who are unwilling to practice an acceptable method of contraception
- •Subjects needing concurrent use of psychiatric medications
- •History of hypersensitivity to paroxetine
- •HADS depression subscale score > 12
- •Failure to respond to an adequate trial of paroxetine (20 mg/day x 8 wks).
研究组 & 干预措施
Paroxetine
Paroxetine 10 mg-40 mg or placebo; flexible dosing; 12-week duration.
干预措施: Paroxetine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Clinician Administered PTSD Scale (CAPS) Scores
时间窗: Change in Scores (12 weeks-Baseline)
Mean change scores in posttraumatic stress disorder symptoms. Raw scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms. The outcome measure is the change in scores before and after treatment. That is, the baseline and at 12 weeks difference scores.
次要结局
- Change in Connor Davidson Resilience Scale Scores(Change in Scores (12 Weeks-Baseline))
- Change in Short PTSD Rating Interview Scores(Change in Scores (12 weeks-Baseline))
- Change in Hospital Anxiety and Depression Scale Scores(Change in Scores (12 Weeks-Baseline))