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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title:

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Dalian Seventh People's Hospital

Current Primary Outcome:

  • the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) [ Time Frame: 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) [ Time Frame: Change from Baseline expression level at 4-week treatment ]
    the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection
  • the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia [ Time Frame: before, after 4 weeks and 8 weeks treatment ]
    The PANSS for estimating the severity of positive and negative symptoms in schizophrenia
  • The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia [ Time Frame: before, after 4 weeks and 8 weeks treatment ]
    The degree of Personal and Social Performance scale(PSP) used to evaluate the disable levels in Multiple dimensions ,especially in social and self-care performance
  • The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment [ Time Frame: 4 weeks and 8 weeks treatment ]
    Main purpose to provide a global rating of illness severity ,improvement and response to treatment for the patients with schizophrenia


Original Secondary Outcome: Same as current

Information By: Dalian Seventh People's Hospital

Dates:
Date Received: November 17, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: December 28, 2016
Last Verified: December 2016