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

NCT ID: NCT03894085

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2022-12-31

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.

Conditions

Anxiety Disorder; Obsessive-Compulsive Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GAD group

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

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

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

PD group

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

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

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

SAD group

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

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

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

OCD group

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

Group Type: EXPERIMENTAL

Paroxetine

Intervention Type: DRUG

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

Healthy controls

MRI scan at baseline and no drugs treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Paroxetine

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 56 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Guo Wenbin

Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbin Guo, MD Ph.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Xiaoxiao Shan, M.D

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, , China

Countries

China

References

Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Shared and distinctive neural substrates of generalized anxiety disorder with or without depressive symptoms and their roles in prognostic prediction. J Affect Disord. 2024 Mar 1;348:207-217. doi: 10.1016/j.jad.2023.12.067. Epub 2023 Dec 29.

Reference Type: DERIVED

PMID: 38160885 (View on PubMed)

Han Y, Yan H, Shan X, Li H, Liu F, Li P, Zhao J, Guo W. Disrupted functional connectivity associated with cognitive impairment in generalized anxiety disorder (GAD) and comorbid GAD and depression: a follow-up fMRI study. J Psychiatry Neurosci. 2023 Nov 7;48(6):E439-E451. doi: 10.1503/jpn.230091. Print 2023 Nov-Dec.

Reference Type: DERIVED

PMID: 37935477 (View on PubMed)

Other Identifiers

2016YFC1307104

Identifier Type: -

Identifier Source: org_study_id