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临床试验/NCT02431845
NCT02431845招募中不适用

Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive

Severance Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

研究概览

简要总结

The purpose of this study is to determine whether pharmaco(epi)genetic study predict selective serotonin reuptake inhibitor (SSRI) responsiveness in advance before the appearance of the drug effect until 4 months(16 weeks), 6 months, and 1 year after administration of SSRIs.

详细描述

The purpose of this study is to determine the effects of (epi)genetic variants on the response to SSRIs in obsessive-compulsive disorder (OCD) subject.

The investigators will recruit drug-naive or drug-free(> 3 months) OCD subjects (n=200). The participants will get SSRIs for their OCD symptoms. The type and dose of SSRIs will not be restricted and will depend on the individual participant's state. However, the investigators will be recommended to follow usual clinical guideline (the Korean treatment algorithm for OCD, 2004). At baseline, 4 month, 6 months, and 1 year after treatment, the participants will be evaluated by Yale-Brown Obsessive-Compulsive Scale(YBOCS), Montgomery Asberg Depression Rating Scale(MADRS), Dimensional Obsessive-Compulsive Scale(DOCS), Toronto alexithymia scale (TAS), interpersonal reactivity index (IRI), Barratt impulsiveness scale (BIS), and the Measure of Constructs Underlying Perfectionism(M-CUP), Beck Depression Inventory(BDI), Beck Anxiety Inventory(BAI), Intolerance of Uncertainty (IOU), Metacognition, Disgust scale, Early Trauma Inventory (ETI). And a part of participants will be taken resting state functional MRI.

The research participants will donate approximately 10-15 ml of blood, from which we will extract DNA and separate serum. Using various (epi)genetic analyses, proteomics, and microbiome analysis (circulating bacterial extracellular vesicles) methods, we will analyze the association of various (epi)genetic variants, protein profiles, microbiome and the anti-obsessive-compulsive responses.

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

盲法说明

Open label study

入排标准

年龄范围
19 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 19~ 70
  • OCD by Diagnostic and Statistical Manual for Mental disorders, 4th edition (DSM-IV)
  • drug naive or drug free for more than 3 months

排除标准

  • any neurological disorder
  • comorbid psychotic disorders
  • alcohol or other substance dependence within past 6 months
  • any evidences for brain diseases

研究组 & 干预措施

SSRIs treatment as usual OCD gruop

Experimental

SSRIs treatment as usual fluoxetine 40~80 mg dose equivalent (fluoxetine, paroxetine, sertraline, fluvoxamine, escitalopram, clomipramine)

干预措施: SSRIs (Drug)

结局指标

主要结局

Change from baseline in the Yale-Brown Obsessive-Compulsive Scale

时间窗: baseline, 3 or 4 months, 6 months, 1 year

rating scale for obsessive-compulsive symptom severity consisting of 10 items

次要结局

  • Change from the baseline Montgomery-Asberg Depression Rating Scale(baseline, 3 or 4 months, 6 months, 1 year)
  • Occurrence of any side effects during the SSRIs treatment(3 or 4 months, 6 months, 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Se Joo Kim

Professor

Severance Hospital

研究点 (1)

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