Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （fMRI） Study With Paroxetine Treatment

Study Overview
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Brief Summary
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To explore reliable neuroimaging biomarkers for anxiety disorder and OCD,and whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD, the investigators included30 drug-naive general anxiety disorder (GAD),30 drug-naïve panic disorder(PD),30 drug-naïve social anxiety disorder,30 drug-naive.obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment. The investigators will also evaluate the severity of symptom, social function, cognitive function and treatment response.

Detailed Description
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Previous studies suggest that there are brain anatomical and functional in patients with anxiety disorder and obsessive-compulsive disorder (OCD). However, it remains unclear whether these abnormalities can be used for the diagnosis of anxiety disorder、OCD and prediction of treatment effects. It is also unclear whether there are shared imaging biomarkers between different subtypes of anxiety disorder and OCD.And it still lacks reliable neuroimaging biomarkers in anxiety disorder and OCD. Based on the previous studies, this study aims to examine the whole-brain anatomical and functional abnormalities in 30 general anxiety disorder (GAD),30 panic disorder(PD),30 social anxiety disorder,30 obsessive-compulsive disorder patients and 30 healthy controls by using a combination of cross-section and longitudinal study designs, including a longitudinal study in patients with anxiety disorder and OCD with 4 weeks of selective serotonin reuptake inhibitor (SSRI) paroxetine treatment.First, neuroimaging biomarkers are definitively selected in subjects at different subtypes of anxiety disorder and OCD population for the purpose of diagnosis by using a cross-section design. After that, a longitudinal study is conducted in patients with anxiety disorder and OCD with 4 weeks of paroxetine 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 of anxiety disorder and OCD, and prediction of treatment effects; and finally be helpful for understanding the pathophysiology of anxiety disorder and OCD.

Official Title
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Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （ fMRI ）Study With Paroxetine Treatment

Conditions
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Anxiety Disorder, Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic criteria for GAD、PD、SAD、OCD patients according to the Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-V) Never received any treatment before,and with no psychotic symptoms For Healthy controls:Their ﬁrst-degree relatives had no history of psychiatric disorders Exclusion Criteria: Exclusion criteria for all participants were any other psychiatric diagnoses according to DSM-V; any physical illness such as liver and kidney diseases, cardiovascular diseases; any combined with other antipsychotic medications (both low and high doses), including typical and atypical antipsychotic,mood stabilizer, antidepressant drugs ; history of drug or alcohol abuse or dependence; obvious suicide attempts or behaviors; pregnancy or lactation. and any contraindications to MRI scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 56 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GAD group<br>General anxiety disorder(GAD) patients meet the diagnostic criteria of 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 4 weeks Paroxetine (20-40mg) treatment for 4 weeks | Drug: Paroxetine<br>* Paroxetine treatment for 4 weeks usage:20-80mg Qd<br>|
| Experimental: PD group<br>Panic disorder(PD) patients meet the diagnostic criteria of 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 4 weeks Paroxetine (20-40mg)treatment for 4 weeks | Drug: Paroxetine<br>* Paroxetine treatment for 4 weeks usage:20-80mg Qd<br>|
| Experimental: SAD group<br>Social anxiety disorder(SAD)meet the diagnostic criteria of 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 4 weeks Paroxetine (20-40mg)treatment for 4 weeks | Drug: Paroxetine<br>* Paroxetine treatment for 4 weeks usage:20-80mg Qd<br>|
| Experimental: OCD group<br>Obsessive-compulsive disorder (OCD)meet the diagnostic criteria of 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 4 weeks Paroxetine(40-80mg) treatment for 4 weeks | Drug: Paroxetine<br>* Paroxetine treatment for 4 weeks usage:20-80mg Qd<br>|
| No Intervention: Healthy controls<br>MRI scan at baseline and no drugs treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structural and function MRI data | A 3.0 T Siemens scanner was used to obtain the fMRI images in the Second Xiangya Hospital of Central South University.The MRI data wii be obtained before and after treatment at different follow up point. | 4 weeks | 
| Hamilton anxiety scale(HAMA) | The change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point. | 4 weeks | 
| Yale-Brown Obsessive Compulsive Scale(Y-BOCS) | The change of the Yale-Brown Obsessive Compulsive Scale(Y-BOCS)total score, severity of obsessive-compulsive symptom before and after treatment at different follow up point. | 4 weeks | 
| Brief Cognitive Assessment Tool for Schizophrenia (B-CATS) | The investigators will use the Brief Cognitive Assessment Toolfor Schizophrenia (B-CATS) score as primary assess of cognitive function before and after treatment at different follow up point. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social Disability Screening Schedule(SDSS) | The investigators will use the Social Disability Screening(SDSS) score as assess of social function before and after treatment at different follow up point. | 4 weeks | 
| Simplified Coping Style Questionnaire (SCSQ) | The investigators will use the Simplified Coping Style Questionnaire(SCSQ) scale score as assess of coping style at baseline and after 4 weeks | 4 weeks | 
| Eysenck Personality Questionnaire(EPQ) | The investigators will use the Eysenck Personality Questionnaire (EPQ) scale as assess of characteristic of personality at baseline | at baseline | 
| The 17-item Hamilton depression scale (HAMD-17) | The change of the 17-item Hamilton depression scale total score, severity of depressive symptom before and after treatment at different follow up point | 4 weeks | 
| Liebowitz social anxiety scale(LSAS) | The change of the Liebowitz social anxiety scale (LSAS) total score,severity of social anxiety before and after treatment at different follow up point. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response