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

NCT ID: NCT04218981

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2023-12-31

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.

Conditions

Common Mental Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Schizophrenia group

1. Schizophrenia was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).

2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks

3. Choose one of the antipsychotics drugs treatment( olanzapine, risperidone, aminosulpiride) according to the patient's condition

Group Type: EXPERIMENTAL

Antipsychotic drugs

Intervention Type: DRUG

Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group

Bipolar disorder group

1. Bipolar disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).

2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks

3. Choose one of the mood stabilizer drugs treatment( lithium, valproate) according to the patient's condition

Group Type: EXPERIMENTAL

Mood stabilizer

Intervention Type: DRUG

Choose lithium or valproate for bipolar disorder group

Major depressive disorder group

1. Major depressive disorder was diagnosed using the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).

2. MRI scan and evaluation of clinical symptoms at baseline and 8 weeks

3. Choose paroxetine treatment

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

Patients with major depressive disorder are treated with paroxetine

Healthy controls

MRI scan at baseline and no drugs treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Antipsychotic drugs

Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group

Intervention Type: DRUG

Mood stabilizer

Choose lithium or valproate for bipolar disorder group

Intervention Type: DRUG

Paroxetine

Patients with major depressive disorder are treated with paroxetine

Intervention Type: DRUG

Other Intervention Names

MRI scan; MRI scan; MRI scan

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Guo Wenbin

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbin Guo

Role: STUDY_DIRECTOR

The Second Xiangya Hospital, Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, , China

Countries

China

Other Identifiers

81771447

Identifier Type: -

Identifier Source: org_study_id