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Trial record 58 of 3310 for:    schizophrenia

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

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ClinicalTrials.gov Identifier: NCT03007303
Recruitment Status : Recruiting
First Posted : January 2, 2017
Last Update Posted : February 2, 2018
Sponsor:
Collaborator:
TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
Information provided by (Responsible Party):
Shoufu Xie, 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.

Condition or disease Intervention/treatment
Schizophrenia Micrognathia Drug: Atypical Antipsychotic Other: atypical antipsychotic combined with MECT

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 8 Weeks
Study Start Date : June 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Group/Cohort Intervention/treatment
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
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 Name: olanzapine, quetiapine , ziprasidone and risperidone

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
Other Name: MECT means modified electric convulsive therapy

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



Primary Outcome Measures :
  1. the Baseline expression profiling of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) [ Time Frame: 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

  2. the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) [ Time Frame: Change from Baseline expression level at 4-week treatment ]
    the plasma samples will be collected from the patients with schizophrenia at the 4-week treatment for the microRNA-30e detection

  3. the Changed expression level of microRNA-30e measured by real-time quantitative poly-chain reaction (QPCR) [ Time Frame: 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 :
  1. the scores of Positive and Negative Syndrome Scale(PANSS) for the patients with schizophrenia [ Time Frame: before, after 4 weeks and 8 weeks treatment ]
    The PANSS for estimating the severity of positive and negative symptoms in schizophrenia

  2. The degree of Personal and Social Performance scale(PSP) for the patients with schizophrenia [ Time Frame: 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

  3. The scale of Clinical Global Impression(CGI) in patients with schizophrenia after treatment [ Time Frame: 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


Biospecimen Retention:   Samples With DNA
The peripheral blood sample Plasma separated from the peripheral blood


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Ages Eligible for Study:   17 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03007303


Contacts
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Contact: Guanghui Fu, postgraduate 86-188 4282 1307 fuguanghui1023@126.com
Contact: Shoufu Xie, postgraduate 86-0411 8451 4015 doctorxie1023@126.com

Locations
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China, Liaoning
Dalian Seventh People's Hospital Recruiting
Dalian, Liaoning, China, 116023
Contact: Guanghui Fu, Postgraduate    86-188 4282 1307    fuguanghui1023@126.com   
Contact: Shoufu Xie, Postgraduate    86-0411 8451 4015    doctorxie1023@126.com   
Sponsors and Collaborators
Dalian Seventh People's Hospital
TAKARA BIOTECHNOLOGY(DALIAN)CO.,LTD.
Investigators
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Principal Investigator: Shoufu Xie, postgraduate Dalian Seventh People's Hospital

Additional Information:

Publications of Results:
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Responsible Party: Shoufu Xie, chief physician,Professor of Psychiatry,Vice president of the hospital, Dalian Seventh People's Hospital
ClinicalTrials.gov Identifier: NCT03007303     History of Changes
Other Study ID Numbers: GFu01
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Micrognathism
Mental Disorders
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities
Olanzapine
Risperidone
Antipsychotic Agents
Quetiapine Fumarate
Ziprasidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents