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临床试验/NCT03007303
NCT03007303Unknown不适用

The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients

Dalian Seventh People's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)

研究概览

简要总结

This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status.

详细描述

The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and the equivalent healthy controls will be conducted with the quantification analysis of the microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).

The 15 patients enrolled should be the first-episode and have not been treated, or were drug free 3 months recently at least.

This research measures the expression level of microRNA-30e in schizophrenia respectively before the beginning treatment with atypical psychotics or combined with MECT, after the 4-week treated , the 8-week treated compared with 15 healthy controls.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
17 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Persons should be diagnosed with schizophrenia according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
  • The first-onset or drug-free in the latest 3 months
  • Between the ages of 17-40

排除标准

  • Comorbid with other psychosis
  • Have physical or neurological diseases such as traumatic brain injuries
  • History of drug-abused or alcoholic
  • Blood transfusion history in a month
  • Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months

研究组 & 干预措施

schizophrenia

15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.

The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated.

干预措施: Atypical Antipsychotic (Drug)

schizophrenia

15 patients with schizophrenia will be treated with anyone of the atypical psychotics(including olanzapine, quetiapine , ziprasidone and risperidone)or combined with MECT.

The fluctuating dosage depends on the changes of symptom according to the total scores of Positive and Negative Syndrome Scale from schizophrenia patients after treated.

干预措施: atypical antipsychotic combined with MECT (Other)

结局指标

主要结局

the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)

时间窗: before the treatment

the plasma samples will be collected from the patients with schizophrenia and the healthy controls at the beginning recruit for the microRNA-30e detection

the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR)

时间窗: Change from Baseline expression level at 8-week treatment

the plasma samples will be collected from the patients with schizophrenia at the 8-week treatment for the microRNA-30e detection

次要结局

  • the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia(before, after 4 weeks and 8 weeks treatment)
  • The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment(4 weeks and 8 weeks treatment)
  • The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia(before, after 4 weeks and 8 weeks treatment)

研究者

发起方
Dalian Seventh People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shoufu Xie

chief physician,Professor of Psychiatry,Vice president of the hospital

Dalian Seventh People's Hospital

研究点 (1)

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