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

• Conditions: Micrognathia; Schizophrenia
• Interventions: Drug: Atypical Antipsychotic; Other: atypical antipsychotic combined with MECT

• Registration Number: NCT03007303
• Lead Sponsor: Dalian Seventh People's Hospital

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 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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2017-01-02
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30
• Primary Completion: 2020-03
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
schizophrenia	Atypical Antipsychotic	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.
schizophrenia	atypical antipsychotic combined with MECT	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.

Primary Outcome Measures

Name	Time	Method
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 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

Name	Time	Method
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 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
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

Trial Locations

Locations (1)

Dalian Seventh People's Hospital; 🇨🇳 Dalian, Liaoning, China