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

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.

Study Overview

• Status: Recruiting
• Conditions: Common Mental Disorder
• Intervention / Treatment: Drug: Antipsychotic drugs; Drug: Mood stabilizer; Drug: Paroxetine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbin Guo, professor; Phone Number: 13875936768; Email: guowenbin76@csu.edu.cn

Study Locations

• China
  • Changsha, China
    • Recruiting
    • The Second Xiangya Hospital of Central South University
    • Contact: Wenbin Guo, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Schizophrenia group; 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	Drug: Antipsychotic drugs; Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group; Other Names: MRI scan
Experimental: Bipolar disorder group; 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	Drug: Mood stabilizer; Choose lithium or valproate for bipolar disorder group; Other Names: MRI scan
Experimental: Major depressive disorder group; 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	Drug: Paroxetine; Patients with major depressive disorder are treated with paroxetine; Other Names: MRI scan
No Intervention: Healthy controls; MRI scan at baseline and no drugs treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 week
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.	8 week
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.	8 week
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.	8 week
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.	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 week

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Study Director: Wenbin Guo, the Second Xiangya Hospital, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: neuroimaging; schizophrenia; bipolar disorder; major depressive disorder
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Disease; Psychotic Disorders; Mental Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine; Antipsychotic Agents
• Other Study ID Numbers: 81771447

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No