Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （ fMRI ）Study With Paroxetine Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hamilton anxiety scale(HAMA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
GAD group
- 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
干预措施: Paroxetine (Drug)
PD group
- 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
干预措施: Paroxetine (Drug)
SAD group
- 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
干预措施: Paroxetine (Drug)
OCD group
- 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
干预措施: Paroxetine (Drug)
结局指标
主要结局
Hamilton anxiety scale(HAMA)
时间窗: 4 weeks
The change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point.
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
时间窗: 4 weeks
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.
structural and function MRI data
时间窗: 4 weeks
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.
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
时间窗: 4 weeks
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.
次要结局
- Social Disability Screening Schedule(SDSS)(4 weeks)
- Eysenck Personality Questionnaire(EPQ)(at baseline)
- The 17-item Hamilton depression scale (HAMD-17)(4 weeks)
- Simplified Coping Style Questionnaire (SCSQ)(4 weeks)
- Liebowitz social anxiety scale(LSAS)(4 weeks)
研究者
Guo Wenbin
Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University
Central South University