Clinical trial NCT04218981: 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
Overall status: COMPLETED
Phase: NA
Conditions: Common Mental Disorder
Keywords: schizophrenia
bipolar disorder
neuroimaging
major depressive disorder
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Resting-state functional magnetic resonance imaging (fMRI) data acquisition for all participants
timeFrame: 8 week
measure: Positive and Negative Syndrome Scale (PANSS)
timeFrame: 8 week
measure: Hamilton Depression Scale-17 (HAMD-17)
timeFrame: 8 week
measure: Young Mania Rating Scale (YMRS)
timeFrame: 8 week
measure: Brief Cognitive Assessment Tool for schizophrenia(B-CATS)
timeFrame: 8 week
Secondary outcomes:
measure: Social Disability Screening Schedule(SDSS)
timeFrame: 8 week
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
affiliation: The Second Xiangya Hospital, Central South University
name: Wenbin Guo
role: STUDY_DIRECTOR
References: