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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

Primary Purpose

Anxiety Disorder, Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paroxetine
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response

Eligibility Criteria

18 Years - 56 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • The Second Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

GAD group

PD group

SAD group

OCD group

Healthy controls

Arm Description

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

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

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

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

MRI scan at baseline and no drugs treatment

Outcomes

Primary Outcome Measures

structural and function MRI data
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.
Hamilton anxiety scale(HAMA)
The 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)
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.
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
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.

Secondary Outcome Measures

Social Disability Screening Schedule(SDSS)
The 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)
The 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)
The 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)
The 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)
The change of the Liebowitz social anxiety scale (LSAS) total score,severity of social anxiety before and after treatment at different follow up point.

Full Information

First Posted
March 18, 2019
Last Updated
February 1, 2021
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03894085
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Obsessive-Compulsive Disorder
Keywords
anxiety disorder, obsessive-compulsive disorder, neuroimaging, biomarkers, treatment response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GAD group
Arm Type
Experimental
Arm Description
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
Arm Title
PD group
Arm Type
Experimental
Arm Description
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
Arm Title
SAD group
Arm Type
Experimental
Arm Description
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
Arm Title
OCD group
Arm Type
Experimental
Arm Description
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
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
MRI scan at baseline and no drugs treatment
Intervention Type
Drug
Intervention Name(s)
Paroxetine
Intervention Description
Paroxetine treatment for 4 weeks usage:20-80mg Qd
Primary Outcome Measure Information:
Title
structural and function MRI data
Description
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.
Time Frame
4 weeks
Title
Hamilton anxiety scale(HAMA)
Description
The change of the Hamilton anxiety scale(HAMA) total score, severity of anxiety symptoms before and after treatment at different follow up point.
Time Frame
4 weeks
Title
Yale-Brown Obsessive Compulsive Scale(Y-BOCS)
Description
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.
Time Frame
4 weeks
Title
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Social Disability Screening Schedule(SDSS)
Description
The investigators will use the Social Disability Screening(SDSS) score as assess of social function before and after treatment at different follow up point.
Time Frame
4 weeks
Title
Simplified Coping Style Questionnaire (SCSQ)
Description
The investigators will use the Simplified Coping Style Questionnaire(SCSQ) scale score as assess of coping style at baseline and after 4 weeks
Time Frame
4 weeks
Title
Eysenck Personality Questionnaire(EPQ)
Description
The investigators will use the Eysenck Personality Questionnaire (EPQ) scale as assess of characteristic of personality at baseline
Time Frame
at baseline
Title
The 17-item Hamilton depression scale (HAMD-17)
Description
The change of the 17-item Hamilton depression scale total score, severity of depressive symptom before and after treatment at different follow up point
Time Frame
4 weeks
Title
Liebowitz social anxiety scale(LSAS)
Description
The change of the Liebowitz social anxiety scale (LSAS) total score,severity of social anxiety before and after treatment at different follow up point.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenbin Guo, M.D.Ph.D
Phone
+8613875936768
Email
guowenbin76@csu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo, MD Ph.D
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoxiao Shan, M.D
Organizational Affiliation
Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenbin Guo, professor
Email
guowenbin76@csu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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