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Status unknownNCT03007303Updated Jan 30, 2020

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

An observational study in Schizophrenia and Micrognathia, sponsored by Dalian Seventh People's Hospital. Status unknown at 1 site in China. Open to participants aged 17 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-30.

Sponsored by Dalian Seventh People's Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
30
Ages
17 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Schizophrenia
  • Micrognathia
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Who can participate

Ages eligible
17 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
30 participants (estimated)
Target follow-up
8 Weeks
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • DrugAtypical 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.

    Also known as: olanzapine, quetiapine , ziprasidone and risperidone

  • Otheratypical 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

    Also known as: MECT means modified electric convulsive therapy

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What researchers measure

Primary outcomes

  1. 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

    Time frame: before the treatment

  2. 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

    Time frame: Change from Baseline expression level at 4-week treatment

  3. 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

    Time frame: Change from Baseline expression level at 8-week treatment

Secondary outcomes

  1. 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

    Time frame: before, after 4 weeks and 8 weeks treatment

  2. 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

    Time frame: before, after 4 weeks and 8 weeks treatment

  3. 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

    Time frame: 4 weeks and 8 weeks treatment

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Study locations

1 of 1 sites recruiting
  • Dalian Seventh People's Hospital
    Dalian, Liaoning 116023, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 27258654 ↗
  • 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. PubMed 20347265 ↗
  • 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. PubMed 23382797 ↗

Individual participant data

Plan to share: Yes

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Registry details

Key details

Study ID
NCT03007303
Lead sponsor
Dalian Seventh People's Hospital
Collaborators
TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
Responsible party
Shoufu Xie (chief physician,Professor of Psychiatry,Vice president of the hospital, Dalian Seventh People's Hospital) — Principal investigator
First posted
Jan 2, 2017
Start date
Jun 2016
Primary completion
Mar 2020 (estimated)
Completion
Jul 2020 (estimated)
Last update
Jan 30, 2020

Study contacts

Guanghui Fu, postgraduate
Contact
fuguanghui1023@126.com
86-188 4282 1307
Shoufu Xie, postgraduate
Contact
doctorxie1023@126.com
86-0411 8451 4015
Shoufu Xie, postgraduate
principal investigator · Dalian Seventh People's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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