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

Central South University

Status: Completed

Conditions: Obsessive-Compulsive Disorder; Anxiety Disorder

Treatments: Drug: Paroxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT03894085

2016YFC1307104

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 56 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 5 patient groups

GAD group

Experimental group

Description:

1. 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) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg) treatment for 4 weeks

Treatment:

Drug: Paroxetine

PD group

Experimental group

Description:

1. 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) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg)treatment for 4 weeks

Treatment:

Drug: Paroxetine

SAD group

Experimental group

Description:

1. 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) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine (20-40mg)treatment for 4 weeks

Treatment:

Drug: Paroxetine

OCD group

Experimental group

Description:

1. 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) 2. MRI scan and evaluation of clinical symptoms at baseline and 4 weeks 3. Paroxetine(40-80mg) treatment for 4 weeks

Treatment:

Drug: Paroxetine

Healthy controls

No Intervention group

Description:

MRI scan at baseline and no drugs treatment