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

Study Overview
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Brief Summary
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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 Description
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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.

Conditions
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Schizophrenia, Micrognathia

Intervention / Treatment
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* Drug: Atypical Antipsychotic
* Other: atypical antipsychotic combined with MECT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| schizophrenia<br>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<br>* 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.<br>* Other names: olanzapine, quetiapine , ziprasidone and risperidone;Other: atypical antipsychotic combined with MECT<br>* 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<br>* Other names: MECT means modified electric convulsive therapy;|
| health controls<br>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?
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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) | 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) | 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) | 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 | 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 | 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 | 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 |