Elucidation of Efficacy Mechanism of N-acetylcysteine in Patients With Posttraumatic Stress Disorder: An 8-week Multimodal Neuroimaging and Neurocognitive Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
研究概览
简要总结
It has been suggested that N-acetylcysteine exerts neuroprotective effects by regulating neurotransmitters and cell signaling pathways. We hypothesize that oral N-acetylcysteine augmentation will help reduce symptoms in patients with posttraumatic stress disorder as well as improve cognitive functions. We also expect that the N-acetylcysteine augmentation will induce change in structural, functional, and neurochemical aspects of the brain.
In this study, we plan to conduct a randomized, double-blind, placebo-controlled augmentation study with N-acetylcysteine in addition to escitalopram. We will assess the efficacy and safety of the N-acetylcysteine augmentation.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-65 year-old male or female
- •Posttraumatic stress disorder diagnosed by SCID-IV
- •Written informed consent
排除标准
- •Medication treatment for posttraumatic stress disorder within 2 weeks
- •Neurologic disease (eg., penetrating or open head injury, epilepsy, multiple sclerosis, brain tumor, cerebrovascular diseases)
- •Any other axis I psychiatric disorder
- •IQ below 80
- •Contraindications to magnetic resosnance imaging (e.g., pacemaker implantation, claustrophobia, etc.)
- •Any psychotropic medication within 2 weeks
- •Unstable medical illness or severe abnormality in laboratory test at screening assessment
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •History of myocardial infarction within 6 months
- •Current diagnosis of duodenal ulcer or asthma
- •Contraindications to drugs used in the study (e.g., epilepsy, uncontrolled narrow-angle glaucoma, etc.)
- •Allergy or intolerance to the study drug
研究组 & 干预措施
N-acetylcysteine + Escitalopram
The subjects with posttraumatic stress disorder, treated with N-acetylcysteine in addition to escitalopram
干预措施: N-acetylcysteine (Drug)
Placebo + Escitalopram
The subjects with posttraumatic stress disorder, treated with placebo in addition to escitalopram
干预措施: Placebo (Drug)
结局指标
主要结局
Changes from baseline in brain structure, function, and biochemical metabolism, analyzed using the computational approach
时间窗: Baseline, 8th weeks
Change from baseline in Clinician-administered PTSD scale scores at 4th weeks
时间窗: Baseline, 4th weeks
Change from baseline in Clinician-administered PTSD scale scores at 8th weeks
时间窗: Baseline, 8th weeks
次要结局
- Change from baseline in Hamilton anxiety rating scale scores at 4th weeks(Baseline, 4th weeks)
- Change from baseline in Hamilton depression rating scale scores at 4th weeks(Baseline, 4th weeks)
- Change from baseline in Hamilton anxiety rating scale scores at 8th weeks(Baseline, 8th weeks)
- Number of participants with adverse events(8th weeks)
- Change from baseline in Hamilton depression rating scale scores at 8th weeks(Baseline, 8th weeks)
研究者
In Kyoon Lyoo
Professor
Ewha Womans University