Combination Treatment for PTSD After the WTC Attack
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the selective serotonin reuptake inhibitor (SSRI) paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
详细描述
Selective serotonin reuptake inhibitor (SSRI) medication is often recommended in combination with cognitive behavioral therapies for PTSD, but combined initial treatment of PTSD has not been studied under controlled conditions. Also, there are few studies of either treatment in survivors of terrorism. This randomized controlled trial evaluates efficacy of combined prolonged exposure (PE) and the SSRI paroxetine in the treatment of survivors of the World Trade Center (WTC) attacks.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Posttraumatic Stress Disorder, chronic, related to World Trade Center Attacks
- •Age 18-70
- •CAPS score greater than 45
- •Willingness to consent
- •For women, negative pregnancy test and using adequate birth control
排除标准
- •Prominent suicidal ideation
- •Current psychotic disorder
- •Unstable medical illness
- •Women who are pregnant or nursing mothers
- •Alcohol or substance use disorder in the past 3 months
- •History of seizure disorder
- •conditions that contraindicate use of paroxetine
- •inability to tolerate a drug free period prior to beginning the study of 4 weeks for MAOIs or fluoxetine and 2 weeks for other psychotropic drugs, except zolpidem for insomnia.
研究组 & 干预措施
Paroxetine
Paroxetine and Prolonged Exposure Therapy
干预措施: Paroxetine (Drug)
Paroxetine
Paroxetine and Prolonged Exposure Therapy
干预措施: Prolonged Exposure Therapy (Behavioral)
Placebo pill
Placebo pill plus Prolonged Exposure Therapy
干预措施: Prolonged Exposure Therapy (Behavioral)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS)
时间窗: Weeks 0,5,10
PTSD severity, minimum = 0 = no symptoms of PTSD maximum = 136 = extremely severe symptoms of PTSD
Number of Participants Who Met Remission Criterion
时间窗: Weeks 5,10
remission defined as: CAPS less than or equal to 20 and Clinical Global Impression (CGI)-change score=1
次要结局
- Treatment Response at Weeks 5 and 10(weeks 5,10)
- Hamilton Depression Scale 0 = no Depression Symptoms 40 = Extreme Depression Symptoms(weeks 0,5,10)
- Quality of Life Enjoyment and Satisfaction Scale Total Score at Week 0,5,10(weeks 0,5,10)
研究者
Franklin Schneier
Research Psychiatrist
Research Foundation for Mental Hygiene, Inc.