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

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03007303
• Other study ID #: GFu01
• Status: Recruiting
• Start date: June 2016
• Est. completion date: July 2020

Study information

• Verified date: January 2020
• Source: Dalian Seventh People's Hospital
• Contact: Guanghui Fu, postgraduate
• Phone: 86-188 4282 1307
• Email: fuguanghui1023[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Micrognathia
• Micrognathism
• Schizophrenia

Intervention

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:
• 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

Locations

Country	Name	City	State
China	Dalian Seventh People's Hospital	Dalian	Liaoning

Sponsors (2)

Lead Sponsor	Collaborator
Dalian Seventh People's Hospital	TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.

Country where clinical trial is conducted

China, 

References & Publications (3)

Banigan MG, Kao PF, Kozubek JA, Winslow AR, Medina J, Costa J, Schmitt A, Schneider A, Cabral H, Cagsal-Getkin O, Vanderburg CR, Delalle I. Differential expression of exosomal microRNAs in prefrontal cortices of schizophrenia and bipolar disorder patients — View Citation

Xu C, Liu X, Song X, Gao Q, Cheng L, Wang L, Zhang K, Xu Y. Aberrant resting state in microRNA-30e rat model of cognitive impairment. Neuroreport. 2016 Aug 3;27(11):809-17. doi: 10.1097/WNR.0000000000000616. — View Citation

Xu Y, Li F, Zhang B, Zhang K, Zhang F, Huang X, Sun N, Ren Y, Sui M, Liu P. MicroRNAs and target site screening reveals a pre-microRNA-30e variant associated with schizophrenia. Schizophr Res. 2010 Jun;119(1-3):219-27. doi: 10.1016/j.schres.2010.02.1070. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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