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

NCT ID: NCT03007303

Last Updated: 2020-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-07-31

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Atypical Antipsychotic

Intervention Type DRUG

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.

atypical antipsychotic combined with MECT

Intervention Type OTHER

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

health controls

15 healthy individuals were collected from Dalian seventh people's hospital and were matched on age and sex to schizophrenia group

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

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

Intervention Type OTHER

Other Intervention Names

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olanzapine, quetiapine , ziprasidone and risperidone MECT means modified electric convulsive therapy

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
Minimum Eligible Age

17 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.

UNKNOWN

Sponsor Role collaborator

Dalian Seventh People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shoufu Xie

chief physician,Professor of Psychiatry,Vice president of the hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shoufu Xie, postgraduate

Role: PRINCIPAL_INVESTIGATOR

Dalian Seventh People's Hospital

Locations

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Dalian Seventh People's Hospital

Dalian, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guanghui Fu, postgraduate

Role: CONTACT

86-188 4282 1307

Shoufu Xie, postgraduate

Role: CONTACT

86-0411 8451 4015

Facility Contacts

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Guanghui Fu, Postgraduate

Role: primary

86-188 4282 1307

Shoufu Xie, Postgraduate

Role: backup

86-0411 8451 4015

References

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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.

Reference Type RESULT
PMID: 27258654 (View on PubMed)

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. Epub 2010 Mar 27.

Reference Type RESULT
PMID: 20347265 (View on PubMed)

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. PLoS One. 2013;8(1):e48814. doi: 10.1371/journal.pone.0048814. Epub 2013 Jan 30.

Reference Type RESULT
PMID: 23382797 (View on PubMed)

Other Identifiers

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GFu01

Identifier Type: -

Identifier Source: org_study_id

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