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

January 28, 2020 updated by: Shoufu Xie, Dalian Seventh People's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • Dalian Seventh People's Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Atypical Antipsychotic
Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.
Other Names:
  • olanzapine, quetiapine , ziprasidone and risperidone
Other: atypical antipsychotic combined with MECT
The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness
Other Names:
  • MECT means modified electric convulsive therapy
health controls
15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before the treatment
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
Change from Baseline expression level at 4-week treatment
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
Change from Baseline expression level at 8-week treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before, after 4 weeks and 8 weeks treatment
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
before, after 4 weeks and 8 weeks treatment
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
4 weeks and 8 weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalian Seventh People's Hospital

Collaborators

TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.

Investigators

  • Principal Investigator: Shoufu Xie, postgraduate, Dalian Seventh People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

December 28, 2016

First Posted (Estimate)

January 2, 2017

Study Record Updates

Last Update Posted (Actual)

January 30, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFu01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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