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

NCT03007303 | Unknown DMC

• 1 other identifier: GFu01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Micrognathia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  before, after 4 weeks and 8 weeks treatment

• The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia

  before, after 4 weeks and 8 weeks treatment

• The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment

  4 weeks and 8 weeks treatment

Study Arms (2)

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; Other: atypical antipsychotic combined with MECT

health controls

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

Interventions

Atypical Antipsychotic 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.

Also known as: olanzapine, quetiapine , ziprasidone and risperidone

schizophrenia

atypical antipsychotic combined with MECT 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

Also known as: MECT means modified electric convulsive therapy

schizophrenia

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

the first-onset schizophrenia patients or drug-free suffers in the last 3 months，who are Chinese of Han descent and admitted to the Dalian Seventh People's Hospital,China

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dalian Seventh People's Hospital: lead
• TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.: collaborator

Study Sites (1)

Dalian Seventh People's Hospital

Dalian, Liaoning, 116023, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 27258654 RESULT

• 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.

  PMID: 20347265 RESULT

• 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.

  PMID: 23382797 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

The peripheral blood sample Plasma separated from the peripheral blood

MeSH Terms

Conditions

Schizophrenia; Micrognathism

Interventions

Olanzapine; Quetiapine Fumarate; ziprasidone; Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Shoufu Xie, postgraduate

  Dalian Seventh People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guanghui Fu, postgraduate

CONTACT

86-188 4282 1307; fuguanghui1023@126.com

Shoufu Xie, postgraduate

CONTACT

86-0411 8451 4015; doctorxie1023@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician，Professor of Psychiatry,Vice president of the hospital

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: January 2, 2017
• Study Start: June 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)