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Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders

Primary Purpose

Common Mental Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Antipsychotic drugs
Mood stabilizer
Paroxetine
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Common Mental Disorder focused on measuring schizophrenia, bipolar disorder, neuroimaging, major depressive disorder

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnostic criteria for schizophrenia,bipolar disorder, major depressive disorder according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • Never received any treatment before.
  • For healthy controls: their first-degree relative had no history of psychiatric disorders.

Exclusion Criteria:

  • The exclusion criteria for all subjects were as follows: any physical illnesses, such as liver, kidney, and cardiovascular diseases; any current or past neuropsychiatric disorders; any traumatic brain injury; seizures; serious impulsive behavior; drug or alcohol addiction; contraindications for MRI; and pregnancy.

Sites / Locations

  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Schizophrenia group

Bipolar disorder group

Major depressive disorder group

Healthy controls

Arm Description

Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition

Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition

Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose paroxetine treatment

MRI scan at baseline and no drugs treatment

Outcomes

Primary Outcome Measures

Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants
A 3.0 T Siemens scanner (Germany) was applied to obtain the MRI images in the Second Xiangya Hospital of Central South University.The MRI data will be obtained before and after treatment at different follow up point.All participants were told to lie on the scanner with their eyes closed. They wore soundproof headphones and asked to remain still. The parameters were as follows: repetition time of 2710 ms, echo time of 3.78 ms, flip angle of 7°, inversion time of 1000 ms, slice thickness of 1 mm, field of view of 256 mm × 256 mm, matrix of 256 × 256, no gap, and 188 slices.
Positive and Negative Syndrome Scale (PANSS)
The PANSS total scores ,subscale scores were used to evaluate the severity of psychotic symptoms at baseline and eight weeks for schizophrenia.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
Hamilton Depression Scale-17 (HAMD-17)
HAMD-17 total scores were used to evaluate the severity of depressive symptoms at baseline and eight weeks for major depressive disorder. The total score of the HAMD-17 was more than 17.The higher scores mean a worse outcome.
Young Mania Rating Scale (YMRS)
YMRS total scores were used to evaluate the severity of manic symptoms for bipolar disorder before and after treatment at different follow up point.The higher scores mean a worse outcome.
Brief Cognitive Assessment Tool for schizophrenia(B-CATS)
The investigators will use the B-CATS scale to assess cognitive function before and after treatment at different follow up point.The higher scores mean a better outcome.

Secondary Outcome Measures

Social Disability Screening Schedule(SDSS)
The investigators will use the SDSS scale to assess social function before and after treatment at different follow up point.The higher scores mean a worse outcome.

Full Information

First Posted
December 27, 2019
Last Updated
August 10, 2020
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04218981
Brief Title
Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders
Official Title
Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To explore the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment. And explore whether there are shared imaging biomarkers between these three common mental disorders.
Detailed Description
Previous studies suggest that there are brain anatomical and functional abnormalities in patients with schizophrenia, bipolar disorder(BD), major depressive disorder(MDD), and the pathogenesis of these three mental disorders may exist overlaps. However, it remains unclear whether these abnormalities can be used for the diagnosis and prediction of treatment effects in mental disorders. It is also unclear whether there are shared imaging biomarkers between these three common mental disorders. In a word, there still lacks reliable neuroimaging biomarkers in mental disorders. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in drug-naive patients with schizophrenia ,drug-naive patients with BD, drug-naive patients with MDD and healthy controls by using a combination of cross-sectional and longitudinal study designs, including a longitudinal study with 8 weeks of drugs treatment( schizophrenia patients are treated with one antipsychotic drug(olanzapine, risperidone; amisulpride); patients with bipolar disorder are treated with one mood stabilizer(lithium;valproate);patients with major depressive disorder are treated with paroxetine). First, neuroimaging biomarkers are definitively selected in patients with different mental disorders for the purpose of diagnosis by using a cross-sectional design. After that, a longitudinal study is conducted in patients after 8 weeks of drugs treatment to validate that the selected neuroimaging biomarkers can be used to predict treatment response of medication. The definitively selected neuroimaging biomarkers are expected to be useful for the diagnosis and prediction of treatment effects in these three mental disorders; and therefore to be helpful for understanding the pathophysiology of mental disorders.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Mental Disorder
Keywords
schizophrenia, bipolar disorder, neuroimaging, major depressive disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Schizophrenia group
Arm Type
Experimental
Arm Description
Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition
Arm Title
Bipolar disorder group
Arm Type
Experimental
Arm Description
Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition
Arm Title
Major depressive disorder group
Arm Type
Experimental
Arm Description
Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). MRI scan and evaluation of clinical symptoms at baseline and 8 weeks Choose paroxetine treatment
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
MRI scan at baseline and no drugs treatment
Intervention Type
Drug
Intervention Name(s)
Antipsychotic drugs
Other Intervention Name(s)
MRI scan
Intervention Description
Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group
Intervention Type
Drug
Intervention Name(s)
Mood stabilizer
Other Intervention Name(s)
MRI scan
Intervention Description
Choose lithium or valproate for bipolar disorder group
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Other Intervention Name(s)
MRI scan
Intervention Description
Patients with major depressive disorder are treated with paroxetine
Primary Outcome Measure Information:
Title
Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants
Description
A 3.0 T Siemens scanner (Germany) was applied to obtain the MRI images in the Second Xiangya Hospital of Central South University.The MRI data will be obtained before and after treatment at different follow up point.All participants were told to lie on the scanner with their eyes closed. They wore soundproof headphones and asked to remain still. The parameters were as follows: repetition time of 2710 ms, echo time of 3.78 ms, flip angle of 7°, inversion time of 1000 ms, slice thickness of 1 mm, field of view of 256 mm × 256 mm, matrix of 256 × 256, no gap, and 188 slices.
Time Frame
8 week
Title
Positive and Negative Syndrome Scale (PANSS)
Description
The PANSS total scores ,subscale scores were used to evaluate the severity of psychotic symptoms at baseline and eight weeks for schizophrenia.The total score of the PANSS was more than 60.The higher scores mean a worse outcome.
Time Frame
8 week
Title
Hamilton Depression Scale-17 (HAMD-17)
Description
HAMD-17 total scores were used to evaluate the severity of depressive symptoms at baseline and eight weeks for major depressive disorder. The total score of the HAMD-17 was more than 17.The higher scores mean a worse outcome.
Time Frame
8 week
Title
Young Mania Rating Scale (YMRS)
Description
YMRS total scores were used to evaluate the severity of manic symptoms for bipolar disorder before and after treatment at different follow up point.The higher scores mean a worse outcome.
Time Frame
8 week
Title
Brief Cognitive Assessment Tool for schizophrenia(B-CATS)
Description
The investigators will use the B-CATS scale to assess cognitive function before and after treatment at different follow up point.The higher scores mean a better outcome.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Social Disability Screening Schedule(SDSS)
Description
The investigators will use the SDSS scale to assess social function before and after treatment at different follow up point.The higher scores mean a worse outcome.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnostic criteria for schizophrenia,bipolar disorder, major depressive disorder according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Never received any treatment before. For healthy controls: their first-degree relative had no history of psychiatric disorders. Exclusion Criteria: The exclusion criteria for all subjects were as follows: any physical illnesses, such as liver, kidney, and cardiovascular diseases; any current or past neuropsychiatric disorders; any traumatic brain injury; seizures; serious impulsive behavior; drug or alcohol addiction; contraindications for MRI; and pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Guo, professor
Phone
13875936768
Email
guowenbin76@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo
Organizational Affiliation
The Second Xiangya Hospital, Central South University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo, professor

12. IPD Sharing Statement

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Definitive Selection of Neuroimaging Biomarkers for the Diagnosis and Treatment to Common Mental Disorders

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