Identification of Multi-modal Bio-markers for Early Diagnosis and Treatment Prediction in Schizophrenia Individuals

December 27, 2018 updated by: Chunshui Yu, Tianjin Medical University General Hospital
This study aims to screen and validate multi-scale bio-markers for early diagnosis and medication monitoring for early schizophrenia, including the genetic, neurobiochemistry, neuroimaging and eletrophysiological measures. Based on the validated bio-markers, the present study further tries to build several prediction models for early differential diagnosis of schizophrenia from healthy controls and other mental diseases (such as the major depression and anxiety disorders), biological sub-typing and diagnosis of the schizophrenia sub-types, and early prediction of the medication effects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia is one of the most important diseases that threaten the health of Chinese people. In view of the current lack of objective biological markers in the diagnosis and treatment of schizophrenia, as well as the lack of effective early diagnosis methods and curative effect prediction methods, the investigators carried out joint research by integrating research teams from molecular genetics, neurobiochemistry, psychiatry, medical imaging, information science and other fields. The overall objective of the project is to establish a bio-marker system for individualized diagnosis and treatment of early schizophrenia. Specific research contents include: screening and verifying multidimensional objective biological markers such as genetics, neurobiochemistry, neuroimaging, electrophysiology, which is related to early diagnosis and efficacy prediction of schizophrenia through big data analysis of healthy controls and patients with first episode schizophrenia, depression and anxiety disorder. Pattern recognition method is used to build the individualized early diagnosis model, biological sub-type clustering model, biological sub-type individualized diagnosis model and early curative effect prediction model of schizophrenia. Based on the individualized diagnosis and treatment prediction model of schizophrenia, the individualized diagnosis and treatment toolkit was developed, and the individualized diagnosis and treatment prediction cloud platform was established to provide assist for clinicians.

Study Type

Interventional

Enrollment (Anticipated)

2700

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria for patients:

  • According with American mental disorder diagnosis and Diagnostic criteria for schizophrenia, major depressive disorder, and anxiety disorder in the statistical manual DSM-IV
  • The time from the onset of symptoms for the first time to participate in study is less than 12 months
  • No any anti-psychotic drugs or medication was taken more than 14 days
  • Han nationality
  • 18 to 45 years old
  • Right-handed

Inclusion Criteria for healthy controls:

  • Han nationality
  • Right-handedness
  • Gender, age and education level are matched with patients
  • 18 to 45 years old
  • Any mental disorder diagnosis in DSM-IV was excluded
  • There were no relatives with severe mental disorder in the two or three generations

Exclusion Criteria:

  • The patient has other psychiatric disorder beside the illness
  • A history of psychoactive substance use, accompanied by severe physical disease
  • Have a history of epilepsy or coma
  • Women who are pregnant or breast-feeding
  • Accompanied by metal implants, claustrophobia and other contraindications of MRI scan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Risperidone
It can be used after schizophrenia is diagnosed. Risperidone affects prolactin and may affect menstruation in young women, so we will try not to use it in such patients. Patients were randomized to a single Risperidone control trial for 8 weeks to evaluate the clinical efficacy of the patients. Risperidone routine daily 2-6 mg, up to 8 mg, can be taken orally twice a day.
Drug: Risperidone
Risperidone tablet
Experimental: Olanzapine
It can be used after schizophrenia is diagnosed. Olanzapine is not generally used in patients with diabetes and hyperlipidemia. Patients were randomized to a single Olanzapine control trial for 8 weeks to evaluate the clinical efficacy of the patients. Olanzapine is available once or twice a day, starting at 5 mg daily and up to 20 mg daily.
Drug: Olanzapine
Olanzapine tablet
Experimental: Aripiprazole
It can be used after schizophrenia is diagnosed. Aripiprazole has no specific contraindications. Patients were randomized to a single Aripiprazole control trial for 8 weeks to evaluate the clinical efficacy of the patients. Aripiprazole is taken orally once a day, starting at 10 mg daily and up to 30 mg daily.
Drug: Aripiprazole
Aripiprazole tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Syndrome Scale (PANSS)
Time Frame: 30-45 minutes
It is a scale involved and standardized for assessing the severity of symptoms of different types of schizophrenia. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale. Each of the 30 items is accompanied by a specific definition as well as detailed anchoring criteria for all seven rating points. The scores for these scales are arrived at by summation of ratings across component items. These seven points represent increasing levels of psychopathology, as follows: 1- absent, 2- minimal, 3-mild, 4-moderate, 5-moderate severe, 6-severe, 7-extreme. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A rating of 7 (extreme) refers to the most serious level of psychopathology in each item, so the higher the score is, the more serious the physical level is.
30-45 minutes
Clinical Global Impression(CGI)
Time Frame: 10-15 minutes
the CGI is a 3-item observer-rated scale that measures illness severity (CGIS), global improvement or change (CGIC) and therapeutic response.The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).CGI-C scores range from 1 (very much improved) through to 7 (very much worse). Treatment response ratings should take account of both therapeutic efficacy and treatment-related adverse events and range from 0 (marked improvement and no side-effects) and 4 (unchanged or worse and side-effects outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Collaborators

Shanghai Mental Health Center
Nanjing Medical University
First Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Harbin Medical University
Tianjin Anding Hospital
Harbin First Specialist Hospital
Anhui Mental Health Center
Wuhan Psychiatric Hospital
Wenzhou Seventh People's Hospital

Investigators

  • Principal Investigator: Chunshui Yu, MD, Tianjin Medical University General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

December 25, 2018

First Submitted That Met QC Criteria

December 27, 2018

First Posted (Actual)

December 31, 2018

Study Record Updates

Last Update Posted (Actual)

December 31, 2018

Last Update Submitted That Met QC Criteria

December 27, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018YFC1314300

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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