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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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03894085
Enrollment
150
Registered
2019-03-28
Start date
2019-05-30
Completion date
2022-12-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety Disorder, Obsessive-Compulsive Disorder

Keywords

anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response

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.

Interventions

DRUGParoxetine

Paroxetine treatment for 4 weeks usage:20-80mg Qd

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 56 Years
Healthy volunteers
Yes

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

*

Design outcomes

Primary

MeasureTime frameDescription
structural and function MRI data4 weeksA 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.
Hamilton anxiety scale(HAMA)4 weeksThe change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point.
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)4 weeksThe 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.
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)4 weeksThe 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.

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026