Clinical trial NCT03894085: Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （fMRI） Study With Paroxetine Treatment
Official title: Definitive Selection of Neuroimaging Biomarkers in Anxiety Disorder and Obsessive-compulsive Disorder: A Longitudinal Functional Magnetic Resonance Imaging （ fMRI ）Study With Paroxetine Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Obsessive-Compulsive Disorder
Keywords: anxiety disorder
obsessive-compulsive disorder
neuroimaging
biomarkers
treatment response
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: structural and function MRI data
timeFrame: 4 weeks
measure: Hamilton anxiety scale(HAMA)
timeFrame: 4 weeks
measure: Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
timeFrame: 4 weeks
measure: Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Social Disability Screening Schedule(SDSS)
timeFrame: 4 weeks
measure: Simplified Coping Style Questionnaire (SCSQ)
timeFrame: 4 weeks
measure: Eysenck Personality Questionnaire(EPQ)
timeFrame: at baseline
measure: The 17-item Hamilton depression scale (HAMD-17)
timeFrame: 4 weeks
measure: Liebowitz social anxiety scale(LSAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
affiliation: Central South University
name: Wenbin Guo, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South University
name: Xiaoxiao Shan, M.D
role: PRINCIPAL_INVESTIGATOR
References: