NCT00560781已完成不适用
Targeting Cognition in PTSD: Pregnenolone Augmentation of SSRIs
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- CAPS, BAC-A
研究概览
简要总结
This study will test the therapeutic potential of augmenting a stable SSRI regimen with the neurosteroid pregnenolone to reduce cognitive symptoms and PTSD symptoms in patients diagnosed with PTSD.
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
- 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
- •18-65 years of age, any ethnic group, either sex
- •DSM-IV diagnosis of PTSD by MINI (see schedule of events)
- •No change in SSRI medications for > 4 weeks.
- •No anticipated need to alter any psychotropic medications for the 10-week duration of the study.
- •Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process.
排除标准
- •Unstable medical or neurological illness, including seizures, CVA, prostate or breast cancer
- •Use of oral contraceptives or other hormonal supplementation such as estrogen.
- •Significant suicidal or homicidal ideation.
- •Concomitant medications for medical conditions will be addressed on a case-by-case base to determine if exclusionary.
- •Current 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
- •Female patients who are pregnant or breast-feeding.
- •Known allergy to study medication.
- •Drugs with a narrow therapeutic index (e.g. thioridazine, mesoridazine, ziprasidone, clozapine, etc.) will be excluded, as suggested by the FDA; patients taking these agents will not be eligible for this study.
研究组 & 干预措施
1
Active Comparator
Pregnenolone
干预措施: Pregnenolone or Placebo (Drug)
2
Placebo Comparator
Placebo
干预措施: Pregnenolone or Placebo (Drug)
结局指标
主要结局
CAPS, BAC-A
时间窗: Prospective
次要结局
- PCL, CD-RISC, CGI, BDI-II(Prospective)
研究者
研究点 (1)
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