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

Sponsor

Dalian Seventh People's Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03007303

Collaborator

TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD. (Other)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Micrognathia	Drug: Atypical Antipsychotic Other: atypical antipsychotic combined with MECT

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Study Start Date :

Jun 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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