NCT01008098Unknown2 期
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change from baseline in Clinician-administered PTSD scale scores at 1st week
研究概览
简要总结
The objectives of the current study are
- to evaluate the efficacy of escitalopram in treatment for post-traumatic stress disorder,
- to find the structural changes of brain using magnetic resonance imaging and its association with the symptoms reduction, and
- to look at the differences of brain imaging findings and symptoms changes according to genetic differences of brain-derived neurotrophic factor (a biological molecule facilitating neuronal growth in human).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 year-old male or female
- •PTSD diagnosed by SCID-IV
排除标准
- •Previous or current treatment history for PTSD
- •Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
- •Any other axis I psychiatric disorder diagnosed by SCID-IV
- •Borderline personality disorder or antisocial personality disorder
- •IQ below 80
- •Any contraindication to MRI scan
- •Any current psychotropic medication
- •Unstable medical illness or severe abnormality in laboratory test at screening assessment
- •Women who are pregnant, breastfeeding, or planning pregnancy
- •Any contraindications to drug used in the study (e.g., allergy, intolerance, etc.)
研究组 & 干预措施
PTSD group
Experimental
干预措施: escitalopram (lexapro) (Drug)
结局指标
主要结局
Change from baseline in Clinician-administered PTSD scale scores at 1st week
时间窗: Baseline, 1st week
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 depression rating scale scores at 1st week(Baseline, 1st week)
- Change from baseline in Hamilton anxiety rating scale scores at 1st week(Baseline, 1st week)
- Number of participants with adverse events(8th weeks)
- Change from baseline in Hamilton depression rating scale scores at 4th weeks(Baseline, 4th weeks)
- Change from baseline in Hamilton depression rating scale scores at 8th weeks(Baseline, 8th weeks)
- Change from baseline in Hamilton anxiety rating scale scores at 4th weeks(Baseline, 4th weeks)
- Change from baseline in Hamilton anxiety rating scale scores at 8th weeks(Baseline, 8th weeks)
研究者
In Kyoon Lyoo, MD, PhD, MMS
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Efficacy of Escitalopram in the Treatment of Internet AddictionInternet AddictionNCT00565422Icahn School of Medicine at Mount Sinai31
已完成
3 期
Brain Imaging and Treatment Studies of the Night Eating SyndromeNight Eating SyndromeNCT01401595University of Pennsylvania87
已完成
3 期
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder in Patients With HIV and AIDSHIV InfectionsAnxiety DisordersNCT00887679Duke University30
已完成
不适用
Lexapro in the Treatment of Patients With Postpartum DepressionPostpartum DepressionNCT00277108University of Rochester20
已完成
3 期
The Efficacy of Escitalopram for Negative Symptoms in SchizophreniaSchizophreniaNCT00148447BeerYaakov Mental Health Center40