Placebo-Controlled Trial of Risperidone Augmentation for SSRI-Resistant Civilian PTSD
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 5
- 主要终点
- Remission of symptoms after 16 weeks
研究概览
简要总结
The purpose of this study is to determine whether the administration of risperidone is effective in the treatment of selective serotonin reuptake inhibitor (SSRI)-resistant post-traumatic stress disorder (PTSD) in civilians.
详细描述
Individuals with PTSD often experience anxiety attacks, nightmares, or repeated unwanted memories after experiencing or witnessing life-threatening events, such as serious accidents or natural disasters, or traumatic events such as physical or sexual abuse.
Risperidone has been approved by the Food and Drug Administration for the treatment of psychotic disorders and has been found helpful for PTSD and depression, but is still considered investigational for the purposes of this study.
All qualified participants will be started on sertraline (Zoloft) for eight weeks. Patients who are still symptomatic at the end of this phase, will be invited to join the second portion of the study where they will be randomly assigned to receive risperidone or placebo (sugar pill) in addition to the sertraline. Participants will be monitored regularly for medication effects, adverse events, and PTSD symptoms.
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
- Double
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
- 是
入选标准
- •Meets criteria for DSM-IV PTSD for a minimum of one month duration
- •Clinician-Administered PTSD Scale (CAPS) score > or = to 50
- •Able to read and complete questionnaires and interviews
- •Negative urine drug screen
排除标准
- •Pregnant or nursing
- •Primary psychotic disorder; psychotic disorder; or cognitive disorder.
- •Prominent suicidal or homicidal ideation
- •Alcohol or substance dependence within 3 months of starting study
- •Primary anxiety disorder or bipolar disorder
- •Patients currently being treated with antipsychotic medication
- •Patients in active psychotherapy aimed at PTSD
- •Combat-related PTSD
结局指标
主要结局
Remission of symptoms after 16 weeks
次要结局
未报告次要终点
研究者
Barbara O. Rothbaum, PhD
Professor
Emory University