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临床试验/NCT02650102
NCT02650102Unknown1 期

The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment

Shanxi Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
发起方
入组人数
200
试验地点
1
主要终点
Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS.

研究概览

简要总结

The aberrant expression of micro-RNAs (miRNAs) has been described in many human diseases, including schizophrenia (SZ). The previous work has indicated a strong genetic association between the miRNA-30e precursor (pre-miR-30e) and the risk of SZ. However, to date, few reports have focused on the expression level of the miR-30 family (miR-30s) and its networks of co-regulation in SZ, even in response to antipsychotic treatment. Given this, the investigator first constructed a hybrid miRNA-TF (transcription factor)-gene-PPI (protein-protein interactions) network focusing on miR-30s by bioinformatics technology. The investigator then selected several candidate miR-30s and key regulators for further validation. These candidates were then quantified by real-time quantitative PCR (qRT-PCR) in an independent cohort of 200 healthy controls and 200 drug-free SZ patients, among which were followed up by 12-week antipsychotic treatment. Furthermore, the investigator evaluated the correlation between the change in gene expression and the improvement of symptoms.

详细描述

Schizophrenia is one of the most serious mental disorder,which is characterized by high prevalence rate ,high recurrence rate, could increase patients' disability and burden of disease. But the pathological mechanism is so far unknown. Until recently, more attention are focused on gene dysregulation hypothesis. The preliminary works of our laboratory prompted that microRNA-30e gene polymorphism and expression abnormal may be related to schizophrenia. Combined with previous studies showed that miRNA disorder involved in neurodevelopmental obstacle and neuropsychiatric disease, the investigators surmised: miR-30e dysregulation can impact the occurrence and development of schizophrenia. This study will carry on the multidimensional research by using the technology of neurobiology, molecular genetics,neuroimaging and so on, and integrate methods of molecular, cell, animal and human body tracking, so as to:(1) Explaining the transcription and regulation mechanisms of target genes of miR-30e,and building the gene regulatory network of schizophrenia as the core of miR-30e.(2)To investigate the pathogenesis of miR-30e participate in schizophrenia, and to evaluate the clinical value of miR-30e in peripheral blood on the disease diagnose, genotyping, predicting efficacy and ending. The object of this study is to provide new scientific data and research ideas for further exploring the neurobiological basis of schizophrenia, and recognize pathophysiological mechanisms of schizophrenia, ultimately to improve and strengthen the new situation in schizophrenia prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Unrelated Han Chinese recruited from the north of China.
  • Drug-free for at least one month before enrollment.
  • Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for SZ (American Psychiatric Association, 1994), relying on the Chinese Version of the Modified Structured Clinical Interview for DSM-IV TR Axis I Disorders Patient Edition (SCID-I/P,11/2002 revision).

排除标准

  • Pregnant or had significant medical conditions.
  • Unstable psychiatric features (e.g., suicidal feelings).
  • A history of substance abuse or drug addiction within the previous 6 months, with the exception of nicotine dependence.
  • Other Axis I co-morbid disorders were not excluded.

研究组 & 干预措施

antipsychotics

Experimental

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

干预措施: Risperidone (Drug)

antipsychotics

Experimental

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

干预措施: Olanzapine (Drug)

antipsychotics

Experimental

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

干预措施: Quetiapine (Drug)

antipsychotics

Experimental

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

干预措施: Aripiprazole (Drug)

antipsychotics

Experimental

This group was treated with one of 5 antipsychotics(risperidone/olanzapine/aripiprazole/quetiapine/ziprasidone) randomly.

干预措施: Ziprasidone (Drug)

结局指标

主要结局

Number of schizophrenics with antipsychptic treatment who achieved remission assessed by PANSS.

时间窗: Number of schizophrenics with 12-week antipsychptic treatment who achieved remission assessed by PANSS.

The clinical effects were assessed by trained and experienced psychiatrists with the Positive and Negative Syndrome Scale (PANSS) before and after 12-week treatment.

次要结局

未报告次要终点

研究者

发起方
Shanxi Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yong Xu

Dr Yong Xu

Shanxi Medical University

研究点 (1)

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