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

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.

Study Overview

• Status: Unknown
• Conditions: Obsessive-Compulsive Disorder; Anxiety Disorder
• Intervention / Treatment: Drug: Paroxetine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenbin Guo, M.D.Ph.D; Phone Number: +8613875936768; Email: guowenbin76@csu.edu.cn

Study Locations

• China
  • Changsha, China
    • Recruiting
    • The Second Xiangya Hospital Of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 56 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GAD group; 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	Drug: Paroxetine; Paroxetine treatment for 4 weeks usage:20-80mg Qd
EXPERIMENTAL: PD group; 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	Drug: Paroxetine; Paroxetine treatment for 4 weeks usage:20-80mg Qd
EXPERIMENTAL: SAD group; 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	Drug: Paroxetine; Paroxetine treatment for 4 weeks usage:20-80mg Qd
EXPERIMENTAL: OCD group; 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	Drug: Paroxetine; Paroxetine treatment for 4 weeks usage:20-80mg Qd
NO_INTERVENTION: Healthy controls; MRI scan at baseline and no drugs treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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	4 weeks
Eysenck Personality Questionnaire(EPQ)	The investigators will use the Eysenck Personality Questionnaire (EPQ) scale as assess of characteristic of personality at baseline	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	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Wenbin Guo, MD Ph.D, Central South University; Principal Investigator: Xiaoxiao Shan, M.D, Central South University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 30, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: March 18, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; neuroimaging; biomarkers; anxiety disorder; treatment response
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Anxiety Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Paroxetine
• Other Study ID Numbers: 2016YFC1307104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No